MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

The third party service agent evaluated the customer's device and verified the reported issue.Physio-control contacted the customer in order to obtain additional information about the patient and event; however, no response was received.Patient fields in which information is 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

A third party service agent contacted physio control to report that their customer's device gave an "abnormal energy delivery" message, which could result in wrong or inappropriate defibrillation therapy being delivered.There was no reports of patient use associated with the reported event.

Manufacturer Narrative

The reported issue was not able to be duplicated.The root cause of the reported issue is unable to be determined.A proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.

Event Description

A third party service agent contacted physio control to report that their customer's device gave an "abnormal energy delivery" message, which could result in wrong or inappropriate defibrillation therapy being delivered.There was no reports of patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 20 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: 10979483
• MDR Text Key: 220673801
• Report Number: 0003015876-2020-01842
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 120