MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Model Number 20

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that their device would not detect the quik-combo therapy cable was connected.The device continued to prompt the end user to "connect cable" even though the cable was connected.As a result, a patient may not be detected and therapy may not be able to be delivered, if necessary.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 the cause of the reported issue was that a low voltage pin had broken off of a quik-combo therapy cable and become lodged in the device's therapy connector assembly.The biomedical engineer replaced the therapy connector assembly, as well as the quik-combo therapy connector, and after observing proper device operation through functional and performance testing the unit was placed back into service for use.The device has not been returned to physio-control for evaluation.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• 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: 4559752
• MDR Text Key: 5459176
• Report Number: 3015876-2015-00241
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• 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: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 3202488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 6 YR
• Event Location: Hospital
• Date Manufacturer Received: 02/06/2015
• Date Device Manufactured: 04/15/2009
• 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