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 10/08/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The customer ordered a replacement therapy connector assembly to repair their device.After observing proper device through functional and performance testing, the device will be returned to use.Physio-control was not able to obtain information on the defibrillation therapy cable assembly or hard paddle assembly that the pin broke off of.Neither the device or the removed therapy connector assembly were 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: 4226676
• MDR Text Key: 4972718
• Report Number: 3015876-2014-01313
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• 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?: No
• Device Age: 12 YR
• Event Location: Hospital
• Date Manufacturer Received: 10/08/2014
• Date Device Manufactured: 12/12/2002
• 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