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 09/07/2021

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.

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

Section e of the initial medwatch report (mfr report # 0003015876-2021-01867) indicated incorrect information.Section e has been updated to reflect the correct information that section e of the initial medwatch report (mfr report # 0003015876-2021-01867) should have indicated.

Manufacturer Narrative

Stryker evaluated the customer's device but was unable to duplicate the reported issue.The user interface pcb assembly and stack flex connector were replaced as a precaution.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Stryker further evaluated the removed user interface pcb assembly and determined that the cause of the reported issue was due to capacitor, designator c181.C181 was cracked and electrically shorted.

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: 12558823
• MDR Text Key: 274251396
• Report Number: 0003015876-2021-01867
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873853863
• UDI-Public: 00883873853863
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160026
• 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,Followup
• Report Date: 12/09/2021

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: 99507-000122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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