MAUDE Adverse Event Report: REMOTE DIAGNOSTIC TECHNOLOGIES LTD. TEMPUS PRO; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 00-1026-R

Device Problems Computer Software Problem (1112); Unable to Obtain Readings (1516)

Patient Problems Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2023

Event Type  Injury  

Event Description

It has been reported to philips that the tempus pro displayed an error message as mpm application ¿ cannot locate mpm application.Exe.Please re-apply with the latest software update.A user report was received related to a reported product problem which is currently being investigated.Further updates will be provided when the investigation is completed.

Manufacturer Narrative

Updated type of complaint - serious injury from product problem.

Manufacturer Narrative

Updated health impact code , component code and conclusion code.

• Brand Name: TEMPUS PRO
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): REMOTE DIAGNOSTIC TECHNOLOGIES LTD.; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 6XW; UK GU14 6XW
• Manufacturer (Section G): REMOTE DIAGNOSTIC TECHNOLOGIES LTD.; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 6XW; UK GU14 6XW
• Manufacturer Contact: jon yard ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 17460454
• MDR Text Key: 320407321
• Report Number: 3003832357-2023-00517
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472441058
• UDI-Public: 05060472441058
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K201746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2023

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: 00-1026-R
• Device Catalogue Number: 989706000101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/01/2024; 05/02/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other