MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	N/A
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	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control provided the customer, a biomedical engineer with technical assistance.Physio-control advised the customer that there is no service repair available or repair parts for their device and it is no longer under warranty.The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient with internal paddles and the device did not shock the patient on the first attempt.They were able to deliver 4 additional shocks to the patient and then obtained a backup device.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient with internal paddles and the device did not shock the patient on the first attempt.They were able to deliver 4 additional shocks to the patient and then obtained a backup device.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient with internal paddles and the device did not shock the patient on the first attempt.They were able to deliver 4 additional shocks to the patient and then obtained a backup device.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.

• Brand Name: LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
• 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: 8606245
• Report Number: 0003015876-2019-00850
• Device Sequence Number: 19590509
• Product Code: MKJ
• UDI-Device Identifier: 00721902148460
• UDI-Public: 00721902148460
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• 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,Followup
• Report Date (Section B): 12/11/2019

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: N/A
• Device Catalogue Number: 99400-000372
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 12/10/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 12/11/2019; 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1