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	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control continues to investigate the reported failure 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 contacted physio-control to report that their device failed to deliver a shock.This issue is patient related; however there was no adverse patient outcome reported.The customer advised physio- control that no additional patient information is available.
Event or Problem Description
The customer contacted physio-control to report that their device failed to deliver a shock.Upon evaluation of the customer's device, physio-control observed an event code in the devices memory.The event code logged in its memory is indicative of a device failure that could result in a failure of the device to charge for defibrillation.This issue is patient related; however there was no adverse patient outcome reported.The customer advised physio- control that no additional patient information is available.
Additional Manufacturer Narrative
Supplemental medwatch report 001 indicates: results code: 114.Supplemental medwatch report 001 should indicate: results code: 213.Supplemental medwatch report 001 indicates: physio control evaluated the customers device and was unable to duplicate the reported issue.Physio replaced the device's therapy pcb assembly to resolve the observed critical event code issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio control reviewed the device data and verified the reported issue.Physio further evaluated the removed therapy pcb, however further cause of the failure to deliver shock could not be determined.Supplemental medwatch report 001 should indicate: physio control evaluated the customers device and was unable to duplicate the reported issue.Physio replaced the device's therapy pcb assembly to resolve the observed critical event code issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio control reviewed the device data and was unable to confirm the reported issue.Physio further evaluated the removed therapy pcb, however further cause of the failure to deliver shock could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device failed to deliver a shock.Upon evaluation of the customer's device, physio-control observed an event code in the devices memory.The event code logged in its memory is indicative of a device failure that could result in a failure of the device to charge for defibrillation.This issue is patient related; however there was no adverse patient outcome reported.The customer advised physio- control that no additional patient information is available.
Additional Manufacturer Narrative
H6: physio control evaluated the customers device and was unable to duplicate the reported issue.Physio replaced the device's therapy pcb assembly to resolve the observed critical event code issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio control reviewed the device data and verified the reported issue.Physio further evaluated the removed therapy pcb, however further cause of the failure to deliver shock could not be determined.

• 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: 8834310
• Report Number: 0003015876-2019-01272
• Device Sequence Number: 14086877
• Product Code: MKJ
• UDI-Device Identifier: 00883873871812
• UDI-Public: 00883873871812
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2019

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: 99577-001945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/20/2019; 10/03/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/06/2019; 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1