MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS INTELLIVUE; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQU

Model Number M4841A

Device Problems Premature Discharge of Battery (1057); Detachment Of Device Component (1104); Low Battery (2584); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2015

Event Type  malfunction  

Event Description

A philips m4841a tele box was assigned and attached to patient.A few minutes later the patient reported to the attending staff member that the telemetry box was getting "warm".The attending staff member checked the box and confirmed that the box was "hot".The telemetry box was dc'ed and sent to biomed for inspection.It was also noted by the telemetry tech that the box was also reading low battery after a very short time.Biomed inspected the tele box and found that the battery terminal wires had come out of their holders and were touching causing a direct short across the battery terminals, which in turn caused a very rapid discharge and heating.A new case was ordered.

• Brand Name: PHILIPS INTELLIVUE
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQU
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 4745049
• MDR Text Key: 5708926
• Report Number: 4745049
• Device Sequence Number: 1
• Product Code: DRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: M4841A
• Device Catalogue Number: M4841A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2015
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2015
• Patient Sequence Number: 1