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

Model Number 15

Device Problem Failure to Power Up (1476)

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

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

Third party service agent evaluated the customer's device and was not able to verify the reported issue.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 third-party service agent contacted stryker to report that their customer's device would not power on.There was no patient use associated with the reported event.

Manufacturer Narrative

Third party service agent was not able to duplicate the reported issue.It was found that the customer uses an inverter in combination with an acpa to power their devices.The following warning is included in the device operating instructions regarding the use of the device with inverters: "potential performance degradation.Physio-control has no information regarding the performance or effectiveness of the lifepak 15 monitor/defibrillator when the power adapter is used with a power inverter.It is the user¿s responsibility to verify that the monitor/defibrillator performs correctly when used with a power inverter".The third party service agent observed that there may be an issue with the electric circuit of the ambulance that could also be contributing to the reported issue.Root cause was not able to be determined.The device passed all functional and performance testing and was returned to the customer.The customer was advised to check the electric circuit of their ambulance, by the ambulance manufacturer.

Event Description

A third-party service agent contacted stryker to report that their customer's device would not power on.There was no patient use associated with the reported event.

• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 12547175
• MDR Text Key: 273792818
• Report Number: 0003015876-2021-01859
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• 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