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

Model Number 15

Device Problem Unexpected Shutdown (4019)

Patient Problem Angina (1710)

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with all the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker evaluated the customer¿s device and verified the reported issue.Stryker downloaded the electronic records of the device and observed the device experienced an inappropriate loss of power.Stryker isolated the cause of the reported issue to the power pcb assembly.Due to a part obsolescence, the device cannot be repaired.The customer was advised to replace their device.The device was sent to be scrapped.

Event Description

The customer contacted stryker to report that their device powered off by itself during a patient event.This issue is patient related; however there was no adverse patient outcome reported by the customer.

Manufacturer Narrative

Stryker determined that the root cause of the reported issue was due to fretting corrosion on the battery wire harness contacts of connector j11 and the mating power pcb assembly contacts of connector p11.The fretting corrosion has been determined to cause an increase in contact resistance which can result in a sudden loss of device power under conditions of high current usage from functions such as printing a code-summary® record.The excessive voltage drop at the contacts triggers the power fail detector circuit on the power board, which causes the device to power cycle.

Event Description

The customer contacted stryker to report that their device powered off by itself during a patient event.This issue is patient related; however there was no adverse patient outcome reported by 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
• 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: 13779730
• MDR Text Key: 287248671
• Report Number: 0003015876-2022-00371
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873912799
• UDI-Public: 00883873912799
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

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: 99577-001217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/16/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2014
• 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
• Patient Age: 77 YR
• Patient Sex: Female