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

Model Number 20E

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

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 displayed a white screen upon power on.This is an indication that the device may be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

Manufacturer Narrative

The customer's device was returned stryker india, but has not been returned to stryker redmond for evaluation, due to local shipping regulations.Stryker verified the reported issue from a photo the customer provided.The cause of the reported issue could not be determined.The returned device was archived by stryker and a replacement device was sent to the customer.H3 other text : device not accessible for testing.

Event Description

The customer contacted physio-control to report that their device displayed a white screen upon power on.This is an indication that the device may be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

Manufacturer Narrative

Stryker redmond further evaluated the customer¿s device and verified the reported issue.Stryker determined that cause of the reported issue was due to capacitor, designator c181.C181 was cracked and electrically shorted.The returned device was archived by stryker redmond.

Event Description

The customer contacted physio-control to report that their device displayed a white screen upon power on.This is an indication that the device may be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported 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
• 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: 12558854
• MDR Text Key: 274252230
• Report Number: 0003015876-2021-01878
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• 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: 99507-000118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• 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