MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Catalog Number VLP12-02B

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control provided the customer, a biomedical engineer, with technical assistance.It was later confirmed by the biomedical engineer that he replaced both the device's therapy connector assembly as well as the damaged hard paddles assembly to resolve the reported issue.After observing proper device operation through functional and performance testing, the unit was placed back into service for use.Neither the device nor the damaged hard paddles assembly were returned to physio-control for evaluation.

Event Description

The customer, a biomedical engineer, contacted physio-control to report that a connector pin had broken-off of a hard-paddles assembly and become lodged in their device's therapy connector assembly.As a result, defibrillation therapy may not be possible.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
• 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: gwen braeger ; 4258674000
• MDR Report Key: 5682666
• MDR Text Key: 46045060
• Report Number: 3015876-2016-00628
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102972
• 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: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VLP12-02B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 14 YR
• Event Location: Hospital
• Date Manufacturer Received: 05/04/2016
• Date Device Manufactured: 10/26/2001
• 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