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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 00-1007-R
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2024
Event Type  malfunction  
Event Description
Philips received a complaint on the tempus pro indicating that the device ecg cable.
 
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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
tanya deschmidt
ascent 1, aerospace centre
aerospace boulevard
farnborough GU14 -6XW
UK   GU14 6XW
MDR Report Key19212598
MDR Text Key341381403
Report Number3003832357-2024-00339
Device Sequence Number1
Product Code MHX
UDI-Device Identifier05060472440013
UDI-Public05060472440013
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K201746
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
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 Number00-1007-R
Device Catalogue Number989706000001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/12/2024
Initial Date FDA Received04/30/2024
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 Number1
Patient Outcome(s) Other;
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