Portable Intensive Care Unit

• • Terminated Z-0937-2011 FDA Unclassified (pre-2012) ·initiated 17 Sep 2010

  Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The loss of the ability to view the patient's Electrocardiogram (ECG) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient.

• • Terminated Z-0343-2007 FDA Unclassified (pre-2012) ·initiated 15 Nov 2006 ·on shared 510(k) K974034

  Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient.

• • Terminated Z-1195-06 FDA Unclassified (pre-2012) ·initiated 30 Jun 2006 ·on shared 510(k) K974034

  The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

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

510(k) Number

K974034 ↗

FDA Product Code

DRO

Device Class

Class II

Regulation

21 CFR Part 870.5550

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Porta Pak 90

  Class II

  FDA 510(k) K840900 Active Cleared 11 Jun 1984

• Dpd Defibrillator

  Class II

  FDA 510(k) K952085 Active Cleared 5 Jun 1995

• Porta Pulse III #D320

  Class II

  FDA 510(k) K833751 Active Cleared 11 Jan 1984

• Portable Intensive Care Unit Modification

  Class III

  FDA 510(k) K983307 Active Cleared 20 Nov 1998

• Mrl Blood Pressure Monitor

  Class II

  FDA 510(k) K885191 Active Cleared 23 May 1989

• 450SLL Defibrillator

  Class II

  FDA 510(k) K874204 Active Cleared 28 Jan 1988

See all devices from Medical Research Laboratories, Inc. →