MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 99400-001790

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control.A third-party service agent evaluated the device and verified the reported issue.After replacing the therapy connector assembly and performing some other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.Device not evaluated by manufacturer.

Event Description

A third-party service agent contacted physio-control to report that a pin from their customer's therapy cable had broken off in the therapy connector.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: meg marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 8528142
• MDR Text Key: 142380536
• Report Number: 0003015876-2019-00685
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K102972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 99400-001790
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2004
• 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