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

Model Number	15
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio downloaded the device's electronic records from the event for review and observed that the device's charge was removed due to the device showing leads off and not recognizing a patient connection.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient while they were implanting an automatic implantable cardioverter-defibrillator (aicd).The users put the patient into v-fib and then the aicd failed.They tried to use the aicd and it failed again.They then charged the device and tried to shock the patient and it did not deliver a shock and the patient's ecg went to a dashed line.They charged the aicd and the device again and were able to deliver a shock to the patient with both devices at about the same time.The patient's rhythm was successfully converted.There were no reports of any adverse effects to the patient as a result of the reported issue.The customer informed physio-control that no additional patient information is available.
Additional Manufacturer Narrative
Physio-control received additional patient information from the customer.Patient information fields a2 and a4 have been updated.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient while they were implanting an automatic implantable cardioverter-defibrillator (aicd).The users put the patient into v-fib and then the aicd failed.They tried to use the aicd and it failed again.They then charged the device and tried to shock the patient and it did not deliver a shock and the patient's ecg went to a dashed line.They charged the aicd and the device again and were able to deliver a shock to the patient with both devices at about the same time.The patient's rhythm was successfully converted.There were no reports of any adverse effects to the patient as a result of the reported issue.The customer informed physio-control that no additional patient information is available.

• Brand Name: LIFEPAK® 15 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: 8735491
• Report Number: 0003015876-2019-01108
• Device Sequence Number: 14021027
• Product Code: MKJ
• UDI-Device Identifier: 00883873872079
• UDI-Public: 00883873872079
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/28/2019

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: 99577-001932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 59