MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 1000 DEFIBRILLATOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Model Number 1000

Device Problem Device Remains Activated (1525)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that their device would intermittently power on by itself.This issue occurred on numerous occasions and the only way to resolve the issue was to remove the device's battery.As a result, defibrillation could be delayed or prevented, if it were necessary.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control evaluated the customer's device and verified the reported issue.Physio observed during testing that when the device's shock button was pressed, the device powered off by itself.Shortly after powering off, the device would then power back on by itself.The only time the device would self-power off was following the 5 minute time-out for the device.Physio removed the device's membrane switch panel for further examination and determined that the cause of the reported issue was that lands 5 and 6 of a connector, designator p5, would intermittently short.The customer was provided with a replacement device.

• Brand Name: LIFEPAK(R) 1000 DEFIBRILLATOR
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer Contact: yuchol kim ; 4258674000
• MDR Report Key: 5617008
• MDR Text Key: 43996825
• Report Number: 3015876-2016-00488
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 3203715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: No
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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