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

Catalog Number UNK_SMP

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control.A third-party service agent evaluated the customer's device and verified the reported issue.After replacing the therapy connector, 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 customer sent their device to the third-party service agent for product maintenance.Upon inspection, it was observed that the therapy connector had a broken pin.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.

Event Description

A customer sent their device to the third-party service agent for product maintenance.Upon inspection, it was observed that the therapy connector had a broken pin.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.

Manufacturer Narrative

Section e1 initial reporter postal code of the initial medwatch report was blank.Section e1 initial reporter postal code of the initial medwatch report should indicate: 4715-052.

• 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
• MDR Report Key: 8776197
• MDR Text Key: 150565042
• Report Number: 0003015876-2019-01182
• 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
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMP
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1