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	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer advised that the nurse who had reported the issue was able to duplicate the issue by manipulating the quik-combo therapy cable.The nurse then installed a new quik-combo therapy cable which resolved the reported issue.The device was then placed back into service for use.The disposition of the removed cable was not reported.The device was not returned to physio-control for evaluation.Device not evaluated by manufacturer.
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.As a result, defibrillation could have been delayed or prevented, if it were necessary.No further details were provided.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.Additionally, the exact date of the reported event was not reported.The customer only advised that the event occurred "about 2-3 months ago.".
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.As a result, defibrillation could have been delayed or prevented, if it were necessary.No further details were provided.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.Additionally, the exact date of the reported event was not reported.The customer only advised that the event occurred "about 2-3 months ago.".
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.Additionally, the customer confirmed that the original quik-combo therapy cable which she had determined had caused the reported issue was disposed of.Therefore the cable is not available to physio-control for evaluation.Finally, the customer advised that the initial reporter was the facility¿s biomedical engineer.Updated sections, accordingly.

• 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: 8374610
• Report Number: 0003015876-2019-00325
• Device Sequence Number: 19364747
• 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: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1