MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 1.4 GHZ INTELLIVUE TELE TRX

Model Number 862439

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Burning Sensation (4540)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

A follow up report will be sent upon completion of investigation.

Event Description

The customer reported that the patient was burned while on the telemetry transmitter.

Manufacturer Narrative

A philips product support engineer examined the device and found wear and some deformation of the battery springs, but not to the extent that a shorted condition can occur.The spring separators in the battery compartment are intact.The device was then examined with batteries installed.The springs compressed and only contacted the negative battery terminals.There was no contact of the battery springs (negative end) with the battery cases (which are connected mechanically to the positive terminals of the batteries).Lastly, two aa batteries were installed in the device and a m1644a 5 lead ecg lead set was connected to the device and to a patient simulator.The device was allowed to operate for three hours.During this time, the temperature of the device remained at about 70.0¿ 72.0 fahrenheit.The injury reported by the customer may have been pressure necrosis and not a burn caused by laying on top of the device for several days.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.

• Brand Name: 1.4 GHZ INTELLIVUE TELE TRX
• Type of Device: 1.4 GHZ INTELLIVUE TELE TRX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hauke schik ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17899491
• MDR Text Key: 325241092
• Report Number: 1218950-2023-00744
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862439
• Device Catalogue Number: 862439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention