MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 20

Device Problems Failure To Run On AC/DC (1001); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that their device switched on automatically and could not be turned off, other than by removing the batteries.During device evaluation it was observed that the device had the service wrench led illuminated, had logged several event codes into the memory and also turned off automatically.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4).Physio-control evaluated the device and verified the reported failure.Physio-control replaced the power supply assembly.Proper device operation was then observed through functional and performance testing.Following repair, the device was returned to the customer for use.

Manufacturer Narrative

Physio-control further evaluated the removed power supply assembly and determined that the cause of the reported failure was due to an integrated circuit (ic) chip, designator u1 on the ac power supply module, that did not have any output.This integrated circuit (ic) chip, designator u1 on the ac power supply module not having output, caused no ac operation and no battery charge.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 4289840
• MDR Text Key: 5052585
• Report Number: 3015876-2014-01432
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 3202487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1