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 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio then replaced the system pcb assembly and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device would not complete the boot-up process.The customer advised that they were attempting to power the device on and observed that the led's on the keypad as well as the display would flash, but the device would not power on.There was patient use associated with the reported event.The customer advised that medical personnel had responded to a patient experiencing a syncopal episode.A backup device was obtained and used to continue patient care.The customer advised that there were no adverse effects to the patient as a result of the reported issue.No further details were provided.Physio-control has made multiple attempts to obtain additional information about both the patient and the event; however, no response has been received.

Manufacturer Narrative

Physio-control further evaluated the removed system pcb assembly and determined that the cause of the reported issue was a thermally sensitive crystal, designator y1.

Event Description

The customer contacted physio-control to report that their device would not complete the boot-up process.The customer advised that they were attempting to power the device on and observed that the led's on the keypad as well as the display would flash, but the device would not power on.There was patient use associated with the reported event.The customer advised that medical personnel had responded to a patient experiencing a syncopal episode.A backup device was obtained and used to continue patient care.The customer advised that there were no adverse effects to the patient as a result of the reported issue.No further details were provided.Physio-control has made multiple attempts to obtain additional information about both the patient and the event; however, no response has been received.

• 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: meg marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 7550261
• MDR Text Key: 109491508
• Report Number: 0003015876-2018-00839
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873884331
• UDI-Public: 00883873884331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1