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

Model Number M4841A

Device Problems Premature Discharge of Battery (1057); Overheating of Device (1437); Split (2537); Device Displays Incorrect Message (2591)

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

Event Date 10/01/2015

Event Type  malfunction  

Event Description

It has been found that philips telemetry units specified can overheat dramatically.This is usually noted by the patient, and will cause a low battery alarm with fairly new batteries.The overheating has split battery casings.Devices use standard aa batteries.We have tried multiple varieties to make sure there was not an issue with the battery.The units are pulled from service and sent to philips for repair; philips claims to replace certain boards or connections, without specifying in detail.Recently the frequency of such incidents has increased.There have been 8 documented incidents at this facility.This has affected m4841a transmitter models with software versions c.00.51 and c.00.58.Manufacturer response for telemetry transmitter, (brand not provided) (per site reporter): philips replaced the outer case and the main power board.

• Brand Name: INTELLIVUE
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover, MA 01810
• MDR Report Key: 5210301
• MDR Text Key: 30701057
• Report Number: 5210301
• Device Sequence Number: 1
• Product Code: DRG
• 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: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: M4841A
• Other Device ID Number: 0106201842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER DEVICES BEING USED AT TIME OF INCIDENT
• Patient Outcome(s): Other