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

Model Number 00-1007-R

Device Problems Unable to Obtain Readings (1516); Failure to Analyze Signal (1539)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It has been reported to philips that during a patient use event, the monitor failed to monitor ecg by 3 lead and 12 lead and failed to display any trace at all on 10 and 12 lead ecg cables, except for a brief initial flicker.The issue continued upon return to base even when different leads were used.There are no known consequences or impact to the patient.

Manufacturer Narrative

Correction made to patient outcome grid from unspecified heart problem to no clinical signs, symptoms or conditions.

• 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: tanya deschmidt ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 16991985
• MDR Text Key: 315837351
• Report Number: 3003832357-2023-00335
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472440013
• UDI-Public: 05060472440013
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-1007-R
• Device Catalogue Number: 989706000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 05/19/2023; 05/19/2023
• Supplement Dates FDA Received: 01/23/2024; 03/21/2024
• 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