MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Model Number 20

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control provide the customer, a biomedical engineer, with technical assistance.The customer later confirmed that the therapy connector assembly of the device and the hard paddles assembly were replaced.After observing proper device through functional and performance testing, the device was returned to use.The device and removed parts were not returned to physio-control for evaluation.

Event Description

The customer contacted physio-control to report that a pin from the defibrillation hard paddles assembly had broken off inside the therapy connector assembly of the device.As a result, defibrillation therapy would not likely be available because another defibrillation therapy cable or hard paddle assembly would not plug into the device.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer Contact: yuchol kim ; 4258674000
• MDR Report Key: 5915931
• MDR Text Key: 53551466
• Report Number: 3015876-2016-01021
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• 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: 99402-000016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/10/2016
• Date Device Manufactured: 08/03/2005
• 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