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

Model Number 15

Device Problem Loss of Power (1475)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Third party service agent evaluated the customer's device and was not able to verify the reported issue.Physio-control contacted the customer in order to obtain additional information about the patient and event; however, no response was received.Patient fields in which information is not provided were intentionally left blank.

Event Description

The third-party service agent contacted physio control to report that their customer's device had unexpectedly lost power during while monitoring a patient.There were no reports of adverse effects to the patient as a result of the reported issue.

Event Description

The third-party service agent contacted physio control to report that their customer's device had unexpectedly lost power during while monitoring a patient.There were no reports of adverse effects to the patient as a result of the reported issue.

Manufacturer Narrative

The reported issue was unable to be verified and unable to be duplicated.Root cause is unable to be determined.The device passed functional and performance testing and was returned to the customer.

• 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: 11646699
• MDR Text Key: 244845249
• Report Number: 0003015876-2021-00770
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2021
• 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: 99577-001394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1