Modification to Lap Top Ventilator (Ltv)

• 3 recalls, same reason

  • Terminated Z-0186-06 FDA Unclassified (pre-2012) ·initiated 9 Nov 2005
  • Terminated Z-0185-06 FDA Unclassified (pre-2012) ·initiated 9 Nov 2005
  • Terminated Z-0184-06 FDA Unclassified (pre-2012) ·initiated 9 Nov 2005

  Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.

• • Terminated Z-1485-04 FDA Unclassified (pre-2012) ·initiated 8 Sep 2004

  Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient.

510(k) Number

K010608 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ltv 1000 Ventilator

  Class II

  FDA 510(k) K051767 Active Cleared 29 Jul 2005

• Pulmonetic Systems Ltv 1200 MR Conditional Ventilator

  Class II

  FDA 510(k) K083688 Active Cleared 18 Mar 2009

• Palmtop Ventilator, Models Ptv-8, Ptv-10

  Class II

  FDA 510(k) K070594 Active Cleared 1 Aug 2007

• Automobile Lighter Power Cord

  Class II

  FDA 510(k) K060549 Active Cleared 4 May 2006

• Ltv 1200 Ventilator

  Class II

  FDA 510(k) K060647 Active Cleared 25 May 2006

• Ltv 1000

  Class II

  FDA 510(k) K984056 Active Cleared 12 Apr 1999

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