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

Catalog Number 99400-000405

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control advised the customer that there is no service repair available or repair parts for their device.Physio recommended that the customer remove the device from service and a replacement device be obtained.The device has not been returned to physio-control for an evaluation.The cause of the reported issue could not be determined.Device not returned to manufacturer.

Event Description

The customer, a biomedical engineer, contacted physio-control to report that their device displayed "service" on the display.As a result, defibrillation energy may not possible, if it were necessary.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
• 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: megan marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 7612027
• MDR Text Key: 111441972
• Report Number: 0003015876-2018-00956
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 99400-000405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2000
• 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