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

Model Number 1000

Device Problems Failure to Power Up (1476); Incorrect Interpretation of Signal (1543); Failure to Sense (1559)

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

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

Stryker continues to investigate the reported failure 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 would not recognize the battery.As a result, the device would not power on and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

Manufacturer Narrative

Section b5, executive summary of the initial medwatch report indicates a customer contacted stryker to report that their device would not recognize the battery.As a result, the device would not power on and defibrillation therapy would not be available if needed.Section b5, executive summary of the initial medwatch report should indicate a customer contacted stryker to report that their device would not recognize the battery and did not recognize a shockable rhythm when tested with a simulator.As a result, defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.Section f10/h6 device code of the initial medwatch indicates failure to power up section f10/h6 device code of the initial medwatch should indicate failure to sense and incorrect interpretation of signal.Stryker evaluated the customer's device and was unable to duplicate or verify the reported issues.A customer quality engineer evaluated the electronic patient record and determined that there was no malfunction determining non shockable versus shockable.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.A cause of the reported issue could not be determined.

Event Description

A customer contacted stryker to report that their device would not recognize the battery and did not recognize a shockable rhythm when tested with a simulator.As a result, defibrillation therapy would not be available if 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: 15760119
• MDR Text Key: 303578038
• Report Number: 0003015876-2022-02458
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160026
• 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: 03/31/2023

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: 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: 10/27/2022
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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