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

Model Number	20
Medical Device Problem Codes	Defective Component (2292); Connection Problem (2900)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control provided the customer with technical assistance.The device was not returned to physio-control for an evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device will not allow a therapy cable to be connected to it.There seems to be a broken pin inside the therapy connector.As a result, defibrillation therapy may be unavailable, if it was needed.
Additional Manufacturer Narrative
Section g5 of the initial medwatch report indicates: combination product is blank.Section g5 of the initial medwatch report should indicate: combination product is no.
Event or Problem Description
The customer contacted physio-control to report that their device will not allow a therapy cable to be connected to it.There seems to be a broken pin inside the therapy connector.As a result, defibrillation therapy may be unavailable, if it was needed.

• Brand Name: LIFEPAK® 20 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 8659756
• Report Number: 0003015876-2019-00937
• Device Sequence Number: 13925464
• Product Code: MKJ
• UDI-Device Identifier: 00883873813812
• UDI-Public: 00883873813812
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 01/25/2020
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1