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

Model Number 20E

Device Problems Failure to Sense (1559); Device Sensing Problem (2917)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the defibrillation therapy cable assembly and observed proper device operation through functional and performance testing.The device was then returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device was unable to detect the defibrillation therapy cable being connected.As a result, defibrillation therapy may not be available if needed.There was no patient use associated with this event.

Manufacturer Narrative

Physio-control further evaluated the removed defibrillation therapy cable assembly.Physio determined that all low voltage pins were shorted together, which caused the reported issue.

Event Description

The customer contacted physio-control to report that their device was unable to detect the defibrillation therapy cable being connected.As a result, defibrillation therapy may not be available if needed.There was no patient use associated with this event.

• Brand Name: LIFEPAK(R) 20E 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: 12099943
• MDR Text Key: 259392408
• Report Number: 0003015876-2021-01341
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99507-000103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THERAPY (QC) CABLE; THERAPY (QC) CABLE