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

Model Number 20E

Device Problem Failure to Sense (1559)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Due to character limitations section e1, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).Stryker performed an initial evaluation of the customer's device and was unable to duplicate the reported issue.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

A customer contacted stryker to report that their device would intermittently loose contact with the electrodes.As a result, defibrillation therapy would not be available if needed.There were no reports of patient use associated with the reported event.

Event Description

A customer contacted stryker to report that their device would intermittently loose contact with the electrodes.As a result, defibrillation therapy would not be available if needed.There were no reports of patient use associated with the reported event.

Manufacturer Narrative

Stryker performed other unrelated repairs and proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.A cause of the reported issue could not be determined.

• 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: 16308753
• MDR Text Key: 308948967
• Report Number: 0003015876-2023-00188
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130454
• 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
• Report Date: 05/16/2023

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: 20E
• Device Catalogue Number: 70507-000164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2022
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2012
• 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