MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; DETECTOR AND ALARM, ARRHYTHMIA

Model Number MX40 1.4

Device Problem No Audible Alarm (1019)

Patient Problems Ventricle, Abnormality Of (2078); Loss of consciousness (2418)

Event Date 08/17/2017

Event Type  malfunction  

Event Description

Patient felt he passed out.Patient showing ventricular standstill on the monitor but the telemetry monitor did not ring for a red alarm.

• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 6886426
• MDR Text Key: 87019916
• Report Number: 6886426
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX40 1.4
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR