MAUDE Adverse Event Report: PHYSIO-CONTROL, INC; ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION

Model Number ACCESSORY

Device Problem Device Sensing Problem (2917)

Patient Problem Death (1802)

Event Date 05/18/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The lifepak 15 monitor/defibrillator that was used with the electrodes during the event, was checked by the biomedical engineer at the customer and no discrepancies were observed; the device was not returned to physio-control.The device was put back into use.  no electronic patient records from the event were available.The electrodes that were used during the event had been disposed of and were not returned to physio.No evaluation could be performed, and therefore no root cause could be determined.

Event Description

It was reported to physio-control that the customer had used quik-combo adult pacing/defibrillation/ecg electrodes together with a lifepak® 15 monitor/defibrillator on a patient, but that there was no movement in the ecg trace on the device's display. when the customer was contacted, they reported that the electrodes were placed on the patient's chest, and that a flat line was observed on the device's screen.The customer confirmed they tested the electrodes that were used during the event with another device but they still observed the same issue.Then the customer tested the device used during the event with another pair of electrodes and the device was working correctly.It was confirmed by the customer that the patient had expired.

• Type of Device: ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer Contact: todd bandy ; 4258674000
• MDR Report Key: 6727372
• MDR Text Key: 80492360
• Report Number: 3015876-2017-00883
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K960329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACCESSORY
• Device Lot Number: 706928
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 06/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death