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

Model Number 862439

Device Problems Premature Discharge of Battery (1057); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2023

Event Type  Death  

Manufacturer Narrative

Section d2: fda procode updated based on information known at this time.Catalog item id and 501k is unknown at time of report.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the customer requested the logs for the telemetry box battery status for the following time frame 21:13 on (b)(6) 2023.A patient death was reported.The device was in use on a patient.There was report of patient or user harm.

Manufacturer Narrative

The philips field service engineer (fse) spoke with the customer and the clinical application specialist (cas).There was a patient death, but the fse advised that it was not related to a failure of equipment.The fse indicated that there were communication issues in notifying the nurse of the low battery and due to the type of battery (not the recommended duracell by philips), the battery went down faster than expected.The customer is using self-maintained m4841 telemetry patient worn devices (pwd's), which are out of support.There was no product malfunction.The onsite investigation by the field service technician revealed that the customer did not use the batteries recommended by philips - user problem.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18326067
• MDR Text Key: 330494592
• Report Number: 1218950-2023-00933
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838022355
• UDI-Public: 884838022355
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death