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

Model Number 15

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customers device and was unable to duplicate the reported issue.After proper device operation was observed through functional and performance testing, the device was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device "defib pads not reading." in this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient involvement associated to this event.

Manufacturer Narrative

Physio-control determined that the cause of the issue was user error.

Event Description

The customer contacted physio-control to report that their device "defib pads not reading." in this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient involvement associated to this event.

• Brand Name: LIFEPAK 15 DEFIBRILLATOR/MONITOR
• 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: 12478798
• MDR Text Key: 271653414
• Report Number: 0003015876-2021-01777
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873871706
• UDI-Public: 00883873871706
• Combination Product (y/n): N
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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: 99577-001956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1