MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

The third party service agent performed an initial evaluation of the customer¿s device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

A third party service agent contacted physio-control to report that the customer¿s device would not complete a boot cycle.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use reported with this event.

Manufacturer Narrative

Additional manufacturer narrative, of the initial medwatch report indicated: the third party service agent performed an initial evaluation of the customer¿s device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Additional manufacturer narrative, of the initial medwatch report should have indicated: code#: 2645, na.Code#: 1663, unlabeled.The third party service agent performed an initial evaluation of the customer¿s device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.New information for supplemental medwatch report: a third-party service agent further evaluated the customer's device and after replacing the system pcb assembly, proper device operation was observed by functional and performance testing.The device was subsequently returned to the customer for use.

Event Description

A third party service agent contacted physio-control to report that the customer¿s device would not complete a boot cycle.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use reported with this event.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 7545415
• MDR Text Key: 109299079
• Report Number: 0003015876-2018-00831
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001008
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1