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

Model Number 15

Device Problem Failure to Deliver Shock/Stimulation (1133)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Physio-control evaluated the customer's device and duplicated the reported issue.Physio replaced the device's quick combo cable to resolve the reported issue.After observing proper device operation 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 failed to deliver shock.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

Stryker further evaluated the removed cable and determined that the cause of the reported issue was a broken high voltage wire at the device connector strain relief.

Event Description

The customer contacted physio-control to report that their device failed to deliver shock.This issue is patient related; however there was no adverse event reported.

• 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 12708484
• MDR Text Key: 278848963
• Report Number: 0003015876-2021-02070
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873911631
• UDI-Public: 00883873911631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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: 99577-001256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1