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

Model Number 15

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The third party service agent downloaded the device's electronic records and provided them to physio-control for review. Upon review, physio-control was able to verify the reported issue. Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56. Device not evaluated by manufacturer.

Event Description

It was reported to a third party service agent that the customer's device would not complete the boot-up process in order to power on. The customer advised that medical personnel attempted to power the device on three times; however, each time the initial physio-control splash screen would appear and the device would power off by itself without completing the boot-up process. As a result, defibrillation would not have been possible if it had been necessary. There was patient use associated with the reported event. The patient was delivered to the hospital in stable condition. There were no reports of adverse effects to the patient as a result of the reported issue.

Manufacturer Narrative

The third party service agent evaluated the customer's device but was unable to duplicate the reported issue. The service agent observed that the battery pin in battery well #1 was visibly lower that the other battery pins. If the battery pin in battery well #1 was making intermittent contact with the battery, this could result in an intermittent loss of power. The service agent repaired the device by replacing the rear case assembly. Additionally, the system pcb assembly was replaced as a precaution. After observing proper device operation through functional and performance testing the unit was returned to the customer for use. The device was not returned to physio-control for evaluation. The cause of the reported issue could not be conclusively determined.

Event Description

It was reported to a third party service agent that the customer's device would not complete the boot-up process in order to power on. The customer advised that medical personnel attempted to power the device on three times; however, each time the initial physio-control splash screen would appear and the device would power off by itself without completing the boot-up process. As a result, defibrillation would not have been possible if it had been necessary. There was patient use associated with the reported event. The patient was delivered to the hospital in stable condition. There were no reports of adverse effects to the patient as a result of the reported issue.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 7657094
• MDR Text Key: 113003284
• Report Number: 0003015876-2018-01034
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 15
• Device Catalogue Number: 99577-001269
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No