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

Model Number 1000

Device Problem Premature Discharge of Battery (1057)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Physio control evaluated the customers device and verified the reported issue.The device and the battery will be sent for a further investigation to the pac (product analysis center).A customer will receive a replacement.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

A customer contacted stryker to report that their device had experienced sudden battery depletion.Upon initial evaluation, stryker observed that the downloaded data showed that the device's battery had suddenly depleted during its daily automated self-test.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no patient use associated with the reported event.

Manufacturer Narrative

The customer's device and battery were further evaluated by stryker.It was observed that the battery was approximately 4 years old.The pac verified that the customer's battery was indeed depleted.No excessive off current was measured from the device.A new non rechargeable battery has a shelf life of five years if stored at the proper conditions.The battery (stored outside the defibrillator) self-discharges over time; therefore, when the battery is eventually placed in the defibrillator, its useful life will be reduced depending on how long it was stored.The depleted battery was verified, however a conclusive cause of the reported issue could not be determined.

Event Description

A customer contacted stryker to report that their device had experienced sudden battery depletion.Upon initial evaluation, stryker observed that the downloaded data showed that the device's battery had suddenly depleted during its daily automated self-test.In this state, the device may not be able to provide defibrillation therapy, if it were needed.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: 12433589
• MDR Text Key: 272170471
• Report Number: 0003015876-2021-01714
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• 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: 99425-000096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• 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