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

Catalog Number 99400-000488

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

Physio control performed an initial evaluation of the customers device and verified the reported issue.Physio is awaiting repair approval.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report a non critical issue upon evaluation physio observed a failed energy output test.In this state the device would not be able to deliver appropriate defibrillation therapy if needed.There was no patient use associated with the reported event.

Event Description

The customer contacted physio-control to report a non critical issue upon evaluation physio observed a failed energy output test.In this state the device would not be able to deliver appropriate defibrillation therapy if needed.There was no patient use associated with the reported event.

Manufacturer Narrative

The customer refused physio-control's recommended repairs and confirmed the device was removed from service.The cause of the reported issue could not be determined.

• Brand Name: LIFEPAK® 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: 9131817
• MDR Text Key: 160451038
• Report Number: 0003015876-2019-01622
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 99400-000488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1