MAUDE Adverse Event Report: PHILIPS INTELLIVUE TRX+; PHYSIOLOGICAL MONITOR, CARDIOVASCULAR

Model Number M4841A

Device Problems Overheating of Device (1437); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2017

Event Type  malfunction  

Event Description

Two telemetry boxes were returned from a nursing unit to the telemetry work station because both of the tele boxes were reported to have overheated and became warm to touch while on a patient.There was no injury to either the patients or the staff.The telemetry technician removed the batteries from the tele boxes and sent both the batteries and tele boxes to biomedical engineering for inspection.Biomedical engineering inspected the tele boxes and found no evidence of cracks, damage, springs were fine, etc.The tele boxes were returned to the telemetry work station and placed back in service as they required no repair.The two sets of batteries, however, did demonstrate signs of overheating (split, melted-appearing covering).The batteries involved were duracell mn1500 size aa.

• Brand Name: INTELLIVUE TRX+
• Type of Device: PHYSIOLOGICAL MONITOR, CARDIOVASCULAR
• Manufacturer (Section D): PHILIPS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 7027247
• MDR Text Key: 92193861
• Report Number: 7027247
• 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: 11/01/2017,11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M4841A
• Other Device ID Number: DURACELL BATTERIES: MN1500, A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1