Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker

• • Terminated Z-1903-2010 FDA Unclassified (pre-2012) ·initiated 27 May 2010 ·on shared 510(k) K012274

  A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power." A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not operate.

• • Terminated Z-1722-2011 FDA Unclassified (pre-2012) ·initiated 27 May 2010 ·on shared 510(k) K012274

  A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted.

• • Terminated Z-0185-2012 FDA Unclassified (pre-2012) ·initiated 30 Dec 2008

  When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.

• • Terminated Z-2388-2008 FDA Unclassified (pre-2012) ·initiated 18 Jun 2008 ·on shared 510(k) K012274

  Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.

• • Terminated Z-1050-2008 FDA Unclassified (pre-2012) ·initiated 8 Jan 2008 ·on shared 510(k) K012274

  Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).

• • Terminated Z-0925-2007 FDA Unclassified (pre-2012) ·initiated 27 Apr 2007 ·on shared 510(k) K012274

  White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.

• • Terminated Z-0886-2007 FDA Unclassified (pre-2012) ·initiated 30 Mar 2007 ·on shared 510(k) K012274

  Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.

• • Terminated Z-1502-06 FDA Unclassified (pre-2012) ·initiated 30 Aug 2006

  Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning.

• • Terminated Z-0711-06 FDA Unclassified (pre-2012) ·initiated 22 Mar 2006

  Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.

• • Terminated Z-0295-2007 FDA Unclassified (pre-2012) ·initiated 16 Mar 2006

  LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.

• 2 recalls, same reason

  • Terminated Z-0116-06 FDA Unclassified (pre-2012) ·initiated 2 Sep 2005
  • Terminated Z-0117-06 FDA Unclassified (pre-2012) ·initiated 2 Sep 2005

  Potential for voltage pins in connector of therapy cable to break.

• • Terminated Z-0984-05 FDA Unclassified (pre-2012) ·initiated 17 Jun 2005

  The defibrillator may not operate if the device is turned on during an AC Loss Alert.

• • Terminated Z-0971-04 FDA Unclassified (pre-2012) ·initiated 5 May 2004

  The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor.

• • Terminated Z-1107-04 FDA Unclassified (pre-2012) ·initiated 5 May 2004 ·on shared 510(k) K012274

  Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG signal; therapy connector has potential for impact damage.

• • Terminated Z-0938-04 FDA Unclassified (pre-2012) ·initiated 5 Apr 2004

  Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.

• • Terminated Z-0294-04 FDA Unclassified (pre-2012) ·initiated 12 Nov 2003 ·on shared 510(k) K012274

  Device unable to recognize the connection to the hard paddles accessory.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K012274 ↗

FDA Product Code

LDD

Device Class

Class II

Regulation

21 CFR Part 870.5300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• LifePak 12 Defibrillator/Monitor System

  Class III

  FDA 510(k) K010918 Active Cleared 23 Aug 2001

• Lifepak 12

  Class III

  FDA 510(k) K040775 Active Cleared 23 Apr 2004

• LifePak 600 Automated External Defibrillator

  Class III

  FDA 510(k) K011144 Active Cleared 3 Dec 2001

• LifePak 500 Automated External Defibrillator

  Class III

  FDA 510(k) K012428 Active Cleared 28 Sep 2001

• Lifepak 12DEFIBERLLATOR/Monitor Series

  Class III

  FDA 510(k) K002445 Active Cleared 31 Jan 2001

• LifePak 12, 20, 500, CR Plus

  Class III

  FDA 510(k) K033275 Active Cleared 6 Nov 2003

See all devices from Medtronic Physio-Control Corp. →