MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio-control duplicated the reported issue when testing the device along with the customer's quik-combo therapy cable.Physio-control then installed a new quik-combo therapy cable and observed proper device operation through functional and performance testing.The device was then returned to the customer for use.The cause of the reported issue was the quik-combo therapy cable.
Event or Problem Description
The customer contacted physio-control to report that during an event their device would intermittently not detect the patient via a quik combo therapy cable and physio-brand therapy electrodes.The customer advised that medical personnel were attempting to shock the patient when the reported issue was observed.Medical personnel then manipulated the cable and were able to obtain a rhythm and continue patient care.A backup device was available, but not used during the event.No further details were provided.The inability to obtain the patient's rhythm during the event could delay or prevent defibrillation if it were necessary.The customer advised that the physio-brand therapy electrodes used during the event were disposed of and therefore not available for evaluation.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control has requested additional information about both the patient and the event; however, no response has been received.
Additional Manufacturer Narrative
The customer responded to physio-control's request for additional information.The customer advised that there were no adverse effects to the patient as a result of the reported issue.The patient survived the event.The customer further advised that they always have access to a backup device (with its own quik-combo therapy cable) available for use, if needed.The customer advised that she was unable to provide any further details about the patient or the event.Finally, the customer also advised that the initial reporter was the facility¿s biomedical engineer.Accordingly.Physio-control further evaluated the removed quik-combo therapy cable and determined that the cause of the reported issue was due to worn out high voltage contacts on the distal quik-combo connector.It was also observed that there was a gap during connection due to a worn out latch on the side of the connector.
Event or Problem Description
The customer contacted physio-control to report that during an event their device would intermittently not detect the patient via a quik combo therapy cable and physio-brand therapy electrodes.The customer advised that medical personnel were attempting to shock the patient when the reported issue was observed.Medical personnel then manipulated the cable and were able to obtain a rhythm and continue patient care.A backup device was available, but not used during the event.No further details were provided.The inability to obtain the patient's rhythm during the event could delay or prevent defibrillation if it were necessary.The customer advised that the physio-brand therapy electrodes used during the event were disposed of and therefore not available for evaluation.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control has requested additional information about both the patient and the event; however, no response has been received.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 8374677
• Report Number: 0003015876-2019-00326
• Device Sequence Number: 11292647
• Product Code: MKJ
• UDI-Device Identifier: 00883873911730
• UDI-Public: 00883873911730
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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 Model Number: 15
• Device Catalogue Number: 99577-001246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1