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

Catalog Number	99400-003486
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control provided technical assistance to the customer.The customer, a biomedical engineer evaluated the device and observed that the device was able to charge and shock at 5 joules.Any energy level greater than 5 joules, and the device was unable to complete a charge cycle.The therapy pcb assembly was replaced and then proper device operation was observed.However, the device was not returned to use, as this device is being replaced by a newer model device.The device was not returned to physio-control, therefore a conclusive of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer, a biomedical engineer contacted physio-control to report that their device was unable to complete a charge cycle for defibrillation, therefore energy delivery would not be available if needed.The customer advised that the device would start the charging cycle, however the charge tone would continue and the charge cycle would not complete.A backup device was available and was used to shock the patient.The customer advised that there were no adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer in order to obtain additional information about both the patient and the event, however, the customer was unable provide further information.

• Brand Name: LIFEPAK(R) 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: 8331737
• Report Number: 0003015876-2019-00244
• Device Sequence Number: 46790
• Product Code: MKJ
• UDI-Device Identifier: 00885074855653
• UDI-Public: 00885074855653
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 02/12/2019

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 Catalogue Number: 99400-003486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1