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

Model Number M4841A

Device Problems Overheating of Device (1437); Split (2537); Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 08/10/2017

Event Type  malfunction  

Event Description

On [date redacted], after placing the batteries in a telemetry box, the box got extremely hot.Upon opening the box and removing the batteries, the team member's fingers were slightly burned after coming in contact with the batteries.The covering of the batteries had separated.These batteries were replaced with new batteries and the box/batteries again began to heat up.It was again noted that the plastic covering of the batteries had split.The telemetry box was removed from circulation and sent to the biomedical department.The team member's slightly burned fingers were treated with bacitracin.No harm to the patient.One month later, a team member reported that the patient's telemetry box was found to be beeping and discovered that the telemetry box was hot to the touch.The team member picked up and then dropped the box (resulting in an area of redness on her hand).The team member opened the battery compartment and noted that the plastic covering on the battery was split and the battery was extremely hot.The battery was removed with folded washcloth.There was no injury to the patient as the tele box was on the patient's bed and not in the usual location (in pocket of gown).The telemetry box and batteries were pulled from service and sent to biomedical engineering to be inspected.Following-up for first event: biomed reported the case of the box was damaged and the battery conductor wires were shorted due to case damage.Telemetry box sent to manufacturer.The batteries that were separated were procells by duracell pc1500.Follow-up to 2nd event: biomed reported the case of the box was not damaged, cracked, etc.The box is an s03 case (thicker style and manufacture date 06/2016).The bus bar retainers are in place.The batteries that were split were procell by duracell pc1500.

• Brand Name: INTELLIVUE TRX+
• Type of Device: PHYSIOLOGICAL MONITOR, CARDIOVASCULAR
• Manufacturer (Section D): PHILIPS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 6975915
• MDR Text Key: 90186644
• Report Number: 6975915
• Device Sequence Number: 1
• Product Code: MSX
• 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: 09/12/2017,10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• 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: (CASE REPLACED MAY 2016), DUR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other