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U.S. Department of Health and Human Services

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

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REMOTE DIAGNOSTIC TECHNOLOGIES LTD. TEMPUS PRO; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) Back to Search Results
Model Number 00-1024-R
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/05/2023
Event Type  malfunction  
Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
 
Event Description
It was reported the device was not booting past the home screen when turned on.There was no patient involvement.
 
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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 Key17202504
MDR Text Key317992719
Report Number3003832357-2023-00407
Device Sequence Number1
Product Code MHX
UDI-Device Identifier05060472441027
UDI-Public05060472441027
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K201746
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number00-1024-R
Device Catalogue Number989706000051
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/05/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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