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 Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio control evaluated the customers device and verified that the device delivered energy in monophasic mode and at times did not power on.It was observed that the system pcb assembly and therapy connectors were loose and not fully seated.They were reseated, and the reported issue was no longer able to be duplicated.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio determined that the loose connectors were the cause of the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device display went blank and shock was not delivered.A blank display can be indicative of a device lock up condition and as a result, defibrillation therapy may be unavailable, if it is needed.The customer was unable to provide any further information for the event or the patient.
Event or Problem Description
The customer contacted physio-control to report that their device display went blank and shock was not delivered.A blank display can be indicative of a device lock up condition and as a result, defibrillation therapy may be unavailable, if it is needed.The customer was unable to provide any further information for the event or the patient.
Additional Manufacturer Narrative
Supplemental medwatch report 001 indicates: physio control evaluated the customers device and verified that the device delivered energy in monophasic mode and at times did not power on.It was observed that the system pcb assembly and therapy connectors were loose and not fully seated.They were reseated, and the reported issue was no longer able to be duplicated.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio determined that the loose connectors were the cause of the reported issue.Supplemental medwatch report 001 should indicate: physio control evaluated the customer's device and the originally reported issue of the device screen going blank after charging and not delivering a shock was not verified.Upon further troubleshooting, it was observed that the device would not turn on and, when tested on a mockup, the device was only delivering a monophasic shock.This issue of device not turning on and delivering a monophasic shock was isolated by the service technician to a loose connection that wasn't fully seated between the system pcba and therapy pcba.The cause of the device screen going blank is unknown but it may also be due to a loose connection between the system pcba and the therapy pcba (reference designator wo1).Proper device operation was observed through functional and performance testing and the device was returned to the customer for use.

• 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: 9107641
• Report Number: 0003015876-2019-01592
• Device Sequence Number: 16740105
• Product Code: MKJ
• UDI-Device Identifier: 00883873872079
• UDI-Public: 00883873872079
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: 09/05/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1