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

Model Number 15

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Shutdown (4019)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

The customer was unable to provide any further information for the event or the patient.Patient fields in which information was not provided were intentionally left blank.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

The customer contacted physio-control to report that their device failed to fire while in use for a patient.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of any adverse effect to the patient as a result of the reported issue, as when the defibrillator failed to deliver the shock, another defibrillator was immediately obtained and the patient was cardioverted.

Manufacturer Narrative

Physio-control evaluated the customers device and was unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control reviewed the device data.Data from the reported event was not available, however review of device data on adjacent days to the reported event verified that on those dates the device failed to respond to the shock button, displayed the "abnormal energy delivered" message and had two occurrences of unexpected loss of power.These issues were not duplicated during testing.The cause of the reported and subsequent noted issues could not be determined.

Event Description

The customer contacted physio-control to report that their device failed to fire while in use for a patient.In this state the device may not be able to deliver defibrillation therapy if needed.During investigation a review of the available device data indicated that it delivered abnormal energy, unexpectedly shutdown and failed to respond to the shock button.In this state the device may not be able to deliver defibrillation or provide inappropriate/delayed therapy if needed.There was no report of any adverse effect to the patient as a result of the reported issue, as when the defibrillator failed to deliver the shock, another defibrillator was immediately obtained and the patient was cardioverted.

• 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
• MDR Report Key: 10394421
• MDR Text Key: 202539970
• Report Number: 0003015876-2020-01039
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873871751
• UDI-Public: 00883873871751
• Combination Product (y/n): N
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• 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: 99577-001951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 90