MAUDE Adverse Event Report: PHILLIPS; PHYSIOLOGICAL MONITOR, CARDIOVASCULAR

Model Number ABAAAMOSES03

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Event Description

Telemetry device gave a "replace battery" notification at approximately 0416.A page was sent to the floor to replace the battery.Per the nurse on the floor, the battery was replaced.At approximately 0535, the monitor gave the same notification to "replace battery" for the telemetry unit.The floor nurse called telemetry and spoke with telemetry supervisor.He informed the supervisor that the batteries had been replaced in the monitor and when he went back to check the telemetry unit, he noticed it was hot to touch.He opened the battery compartment to find the batteries were "melting".Telemetry supervisor advised nurse to immediately send the unit to the telemetry department.Upon inspection by telemetry supervisor, it was found that the monitor was overheated.It was taken out of service and replaced with a functioning monitor.The monitor had been on the patient for four days before the overheating occurred.No patient harm occurred.

• Type of Device: PHYSIOLOGICAL MONITOR, CARDIOVASCULAR
• Manufacturer (Section D): PHILLIPS; 3000 minuteman rd; andover MD 01810
• MDR Report Key: 7288431
• MDR Text Key: 100669729
• Report Number: 7288431
• Device Sequence Number: 1
• Product Code: MHX
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ABAAAMOSES03
• Device Lot Number: 862439
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO