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 Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that a pin had broken off of a quik-combo therapy cable assembly and become lodged into their device's therapy connector assembly.This issue was discovered during patient use, however no further details about the event were provided and no adverse effects to the patient were reported as a result of the reported issue.

Manufacturer Narrative

(b)(4).Physio-control provided the customer with troubleshooting assistance, as well as assisted the customer with ordering a new quik-combo therapy cable assembly and replacement therapy connector assembly needed in order to complete the repair.Once the repair has been completed, and after observing proper device operation through functional and performance testing, the device will be placed back into service for use.Neither the device, nor the quik-combo therapy cable assembly were returned to physio 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: 3732290
• MDR Text Key: 16917741
• Report Number: 3015876-2014-00382
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• 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?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2014
• Date Device Manufactured: 08/23/2002
• 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