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

Model Number 00-1024-R

Device Problem Erratic Results (4059)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2022

Event Type  malfunction  

Event Description

As described by the customer 'monitor tends to give inaccurate 02 sat readings.The tempus will give a reading of say 70% when the patient's presentations simply doesn't reflect.The crews advise me that they will change over to one of our portable o2 sat monitors and get a reading in the 90's.I have also received reports of fluctuating heart rates.The monitor will display a heart rate of say 20 to 30, when the patient's palpable pulse is 60-70.We have checked to ensure that the heart rate is reading off of the ecg and not the o2 sat pleth thinking this could have been the reason for the inaccurate rates.Screen has also frozen at times.Device return is planned to do an investigation and root cause analysis.

Event Description

As described by the customer 'monitor tends to give inaccurate 02 sat readings.The tempus will give a reading of say 70% when the patient's presentations simply doesn't reflect.The crews advise me that they will change over to one of our portable o2 sat monitors and get a reading in the 90's.I have also received reports of fluctuating heart rates.The monitor will display a heart rate of say 20 to 30, when the patient's palpable pulse is 60-70.We have checked to ensure that the heart rate is reading off of the ecg and not the o2 sat pleth thinking this could have been the reason for the inaccurate rates.Screen has also frozen at times.The device log files was investigated by rdt and no problem was found.The device however reported several ' ecg lead off' errors through out the logs.This could be an indication that this cable was being used incorrectly or there is a fault with the cable.It is recommended that customer be supplied with a new ecg and spo2 cable.The customer should notify rdt if the problem persists with the new cables.

• Brand Name: TEMPUS PRO
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): REMOTE DIAGNOSTIC TECHNOLOGIES (RDT); ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• Manufacturer (Section G): REMOTE DIAGNOSTIC TECHNOLOGIES (RDT); ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• Manufacturer Contact: selvaganesan balu ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 15322920
• MDR Text Key: 303629842
• Report Number: 3003832357-2022-00023
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472441027
• UDI-Public: 05060472441027
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

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: 00-1024-R
• Device Catalogue Number: 989706000051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 09/29/2022
• 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): Other