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

Model Number 15

Device Problem Failure to Capture (1081)

Patient Problem Arrhythmia (1721)

Event Date 05/30/2022

Event Type  Death  

Manufacturer Narrative

The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.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

The customer contacted stryker to report that their device failed to capture during transcutaneous pacing.The patient involved in the reported event is deceased.

Event Description

The customer contacted stryker to report that their device failed to capture during transcutaneous pacing.The patient involved in the reported event is deceased.

Manufacturer Narrative

Stryker perform a clinical review of the event and concluded that the device use may have contributed to the patient's outcome.Stryker reviewed the electronic patient record from the event and observed a shockable rhythm at time 1:29:50 pm and the first shock delivered at time 1:44:21 pm, defibrillation was delivered appropriately.There were 14 minutes and 28 seconds before energy was delivered, most likely due to use error.Prior to the patient being in a shockable rhythm, electrical capture during pacing was observed.The customer reported no evidence of mechanical capture.Electrical capture does not ensure mechanical capture.

Manufacturer Narrative

Stryker evaluated the customer's device and was able to verify but not duplicate the reported issue.Proper device operation was observed through functional and performance testing and the device was returned to the customer for use.

Event Description

The customer contacted stryker to report that their device failed to capture during transcutaneous pacing.The patient involved in the reported event is deceased.

• 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: 14951461
• MDR Text Key: 295471429
• Report Number: 0003015876-2022-01415
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 07/20/2022; 10/19/2022
• Supplement Dates FDA Received: 07/29/2022; 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2020
• 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 Outcome(s): Death
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 100 KG