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

Model Number 15

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control performed an initial evaluation of the customer¿s device and verified 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

The customer contacted physio-control to report that their device recorded "abnormal energy" on printout during a shift check.In this state, wrong defibrillation therapy may be delivered to the patient.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control further evaluated the customer's device and determined that the cause of the reported issue was due to a loose isolation relay connector.Physio properly reseated the connector, and then after other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device recorded "abnormal energy" on printout during a shift check.In this state, wrong defibrillation therapy may be delivered to the patient.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: 12594918
• MDR Text Key: 275425827
• Report Number: 0003015876-2021-01926
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873911648
• UDI-Public: 00883873911648
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

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: 15
• Device Catalogue Number: 99577-001255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2013
• 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