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 04/07/2015

Event Type  malfunction  

Event Description

The customer contacted physio-control for service on their device.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that a pin from a therapy cable assembly had broken off and become lodged in the device's therapy connector assembly.As a result, defibrillation would not be possible.

Manufacturer Narrative

Physio-control evaluated the customer's device and verified the reported issue.Physio then replaced the device's therapy connector assembly and completed other, unrelated, repairs.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio further examined the removed therapy connector assembly and determined that the cause of the reported issue was that a broken pin was lodged in low voltage socket 1.

• 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: 4796614
• MDR Text Key: 21470261
• Report Number: 3015876-2015-00584
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• 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: 3202487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: 12 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2003
• 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