MAUDE Adverse Event Report: STRYKER LIFEPAK 15 LP-7; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number LP15

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 11/02/2023

Event Type  malfunction  

Event Description

Paramedic responded to an elderly patient in cardiac arrest.The operator set the energy to 360j and pressed the charge button.While the lifepak was charging, it shut itself off and after 5-10 seconds turned itself back on.No shock was delivered, and the charge was dumped.The operator repeated their steps, and the issue occurred a second time.On the third attempt of charging the monitor, it functioned normally and delivered a shock.After the patient call, the operator powered off the lifepak and turned it back on, and then used the test block to deliver energy and found the issue did not repeat itself again.This issue resulted in a 20 to 30 second delay in patient care.Upon investigation, one of the device¿s batteries was found to be full and the other had a low charge (1-2 green bars).No other buttons were found to be inadvertently pressed that would have caused the unit to power off.The lifepak¿s code summary shows the device shut itself off and powered on its own and the lifepak did not create a new case/patient as expected if an operator had manually shut off the monitor and turned it back on.Stryker came in and investigated the lifepak.The recommendation from stryker was to replace all batteries that were manufactured before 2022.Biomed¿s investigation concluded that the device most likely tried to use the low battery twice before switching to the use of the fully charged battery.Manufacturer response for monitor, physio control lp 15 (per site reporter).Stryker sent a technician to evaluate this monitor and another we had an issue with.The recommendation was to replace all batteries manufactured before 2022.

• Brand Name: LIFEPAK 15 LP-7
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): STRYKER; 1901 romence pkwy; portage MI 49002
• MDR Report Key: 18483788
• MDR Text Key: 332553662
• Report Number: 18483788
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/21/2023

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: Health Professional
• Device Model Number: LP15
• Device Catalogue Number: MH-26518B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2023
• Device Age: 8 YR
• Event Location: Other
• Date Report to Manufacturer: 01/10/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Male