MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 1000

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer¿s device and verified the reported issue.Physio determined that the cause of the reported issue was due to a broken solder joint on pin 8 of the h-bridge.A cable was pressing down on the h-bridge which resulted in the broken solder joint.The customer was sent a replacement device.

Event Description

The customer contacted physio-control to report a non-critical issue with their device.Upon evaluation of the customer¿s device, physio-control observed that the device displayed an ¿abnormal energy¿ message when attempting to shock into a simulator.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 1000 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: 11391891
• MDR Text Key: 234010511
• Report Number: 0003015876-2021-00494
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873815458
• UDI-Public: 00883873815458
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122600
• 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
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000
• Device Catalogue Number: 99425-000023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2017
• 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