MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20

Device Problem Device Inoperable (1663)

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

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer, a biomedical engineer, advised that upon evaluation of their device he was unable to duplicate 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.

Event Description

The customer, a biomedical engineer, contacted physio-control to report that their device locked up during an event.The device was to be used in the cath lab and it powered on/off without issue, but was otherwise unresponsive when buttons were pressed.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer in an effort to obtain additional information about both the patient and the event.Physio-control was advised that no further details are available.

Manufacturer Narrative

It was later confirmed by the customer, a biomedical engineer, that after observing proper device operation through functional and performance testing the device was placed back into service for use.The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.

Event Description

The customer, a biomedical engineer, contacted physio-control to report that their device locked up during an event.The device was to be used in the cath lab and it powered on/off without issue, but was otherwise unresponsive when buttons were pressed.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer in an effort to obtain additional information about both the patient and the event.Physio-control was advised that no further details are available.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• 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: 7614120
• MDR Text Key: 111705374
• Report Number: 0003015876-2018-00962
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• 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,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 97402-000002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2003
• 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