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

Model Number 15

Device Problems Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 10/09/2023

Event Type  Death  

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 was 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

A customer contacted stryker to report that the electrodes had to be replaced due to heavy lotion on the patient's chest and their device had displayed abnormal energy message during patient use.As a result, appropriate defibrillation therapy would not be delivered, if needed.The patient associated to the reported event did not survive.

Manufacturer Narrative

The clinical review of the reported event was performed and it was concluded that there are insufficient data within the file to determine the impact of the device use.There was inadequate contextual information from the patient¿s data file to identify the appropriate patient¿s event.Because the ecg was unavailable, it is unknown if the patient was in a shockable rhythm at the time of the event.In the medical judgment of these reviewers, it is unknown if the device caused or contributed to the reported outcome.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 the electrodes had to be replaced due to heavy lotion on the patient's chest and their device had displayed abnormal energy message during patient use.As a result, appropriate defibrillation therapy would not be delivered, if needed.The patient associated to the reported event did not survive.

Event Description

A customer contacted stryker to report that the electrodes had to be replaced due to heavy lotion on the patient's chest and their device had displayed abnormal energy message during patient use.As a result, appropriate defibrillation therapy would not be delivered, if needed.The patient associated to the reported event did not survive.

Manufacturer Narrative

The device was not returned to stryker for further evaluation as the customer scrapped the device.The reported issue was unable to be verified and the cause of the issue is unknown.H3 other text : device not returned to manufacturer.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18084585
• MDR Text Key: 327536519
• Report Number: 0003015876-2023-02040
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873911631
• UDI-Public: 00883873911631
• 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,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001256
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2014
• 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 Outcome(s): Death
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 82 KG