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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and was unable to duplicate the reported issues.Physio downloaded the electronic records from the customer¿s device and was able to confirm that their device experienced an inappropriate loss of power.Physio-control continues to investigate the reported issue 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, a biomedical engineer contacted physio-control to report that their device cycled power by itself twice during a patient event.The customer advised that the device cycled power the first time after a blood pressure reading was taken while the apnea alarm was sounding.Shortly thereafter, the device cycled power again.After the second power cycle, the device functioned properly for the rest of the case.The device was reported to be stationary and connected to ac power.The patient was being monitored only.The customer advised that there were no adverse effects to the patient as a result of the reported issue.The customer was unable to provide further details on the event or the patient.Each time the device was powered back on by the customer.After the last power off, the customer removed and reseated the batteries.Thereafter, proper device operation was observed for the rest of the patient transport.The device was used for patient monitoring only.The patient, a (b)(6) year old female did survive.The customer advised that there were no adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Physio-control further evaluated the customer's device and was unable to duplicate the reported issue.As a precaution, the power pcb assembly was replaced and then proper device operation was observed through functional and performance testing.The device was returned to the customer for use.As initially reported, a review of the downloaded electronic data confirmed that the customer's device experienced an inappropriate loss of power, however the cause of this could not be determined.
Event or Problem Description
The customer, a biomedical engineer contacted physio-control to report that their device cycled power by itself twice during a patient event.The customer advised that the device cycled power the first time after a blood pressure reading was taken while the apnea alarm was sounding.Shortly thereafter, the device cycled power again.After the second power cycle, the device functioned properly for the rest of the case.The device was reported to be stationary and connected to ac power.The patient was being monitored only.The customer advised that there were no adverse effects to the patient as a result of the reported issue.The customer was unable to provide further details on the event or the patient.Each time the device was powered back on by the customer.After the last power off, the customer removed and reseated the batteries.Thereafter, proper device operation was observed for the rest of the patient transport.The device was used for patient monitoring only.The patient, a 75 year old female did survive.The customer advised that there were no adverse effects to the patient as a result of the reported issue.

• 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: 8553237
• Report Number: 0003015876-2019-00715
• Device Sequence Number: 11198445
• Product Code: MKJ
• UDI-Device Identifier: 00883873871645
• UDI-Public: 00883873871645
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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): 05/23/2019

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: 99577-001962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1