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 12/15/2014

Event Type  malfunction  

Event Description

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

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 the device's therapy connector as well as the hard paddles assembly which resolved 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 hard paddles, have been returned to physio-control for evaluation.

• 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 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: 4388524
• MDR Text Key: 16541957
• Report Number: 3015876-2015-00017
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• 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: 12 YR
• Event Location: Hospital
• Date Manufacturer Received: 12/15/2014
• Date Device Manufactured: 10/24/2002
• 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