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 03/10/2014

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that a pin from a quik-combo therapy cable assembly had broken off and become lodged into their device's therapy connector assembly.As a result, the device would not recognize paddles lead ecg and would not have defibrillated, if necessary.There was no patient use associated with the reported event.

Manufacturer Narrative

The customer, a biomedical engineer, contacted physio-control to report that he replaced the therapy connector 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.The biomedical engineer also advised that they disposed of the quik-combo therapy cable assembly that had the broken pin and will likely use another cable from their inventory.The device has not been returned to physio-control for evaluation.

Manufacturer Narrative

(b)(4).Physio-control provided the customer, a biomedical engineer, with troubleshooting assistance as well as the part number for a replacement therapy connector assembly.Numerous attempts to contact the customer and verify the resolution of the reported failure have been unsuccessful and no response from the customer appears to be forthcoming.The device has not been returned to physio-control for evaluation.The cause of the reported failure could not be determined.

• 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: 3728985
• MDR Text Key: 4276045
• Report Number: 3015876-2014-00372
• 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,Followup
• Report Date: 03/10/2014

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
• Device Lot Number: 0411
• Other Device ID Number: 3006570-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 9 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2005
• 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