MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO¿ ELECTRODES WITH REDI-PAK¿ PRECONNECT SYSTEM; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	11130-000037
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control 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 or Problem Description
The customer contacted physio-control to report that their therapy cable was "bad" and not working.As a result, defibrillation therapy may have been unavailable, if it was needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the customer's therapy cable and verified the reported issue.Physio determined that the cause of the reported issue was due to all 6 low voltage pins being shorted together.The customer received a replacement therapy cable.
Event or Problem Description
The customer contacted physio-control to report that their therapy cable was "bad" and not working.As a result, defibrillation therapy may have been unavailable, if it was needed.There was no report of patient use associated with the reported event.

• Brand Name: QUIK-COMBO¿ ELECTRODES WITH REDI-PAK¿ PRECONNECT SYSTEM
• 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: 8814217
• Report Number: 0003015876-2019-01251
• Device Sequence Number: 13525492
• Product Code: MKJ
• UDI-Device Identifier: 00883873796139
• UDI-Public: 00883873796139
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960329
• 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): 09/03/2019

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 Catalogue Number: 11130-000037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1