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 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). physio-control provided the customer with technical assistance.  it was later confirmed by the customer that the therapy connector assembly was replaced to resolve the reported issue. after observing proper device operation through functional and performance testing, the unit was placed back into service for use. the device has not been returned to physio-control for evaluation.

Event Description

The customer contacted physio-control to report that their device's therapy connector had a broken pin lodged inside one of the sockets.As a result, defibrillation was not possible because neither a hard paddles assembly or a therapy cable could be connected in order to provided therapy.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; redmond WA 98073 9706
• Manufacturer Contact: yuchol kim ; 4258674000
• MDR Report Key: 6000980
• MDR Text Key: 56500839
• Report Number: 3015876-2016-01181
• 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,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• 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: 99402-000033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Date Manufacturer Received: 09/12/2016
• Date Device Manufactured: 05/27/2005
• 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