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 Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

As per customer ' tempus pro - shut down while in patient use, powered back up and performed self test.Log files under review for the evaluation.

Event Description

Customer reported ' tempus pro - shut down while in patient use, powered back up and performed self test.Upon receipt of the device logs the rdt performed an in depth analysis with the support of mindteck.And confirmed there was no software issues could be identified that attributed to the tempus restart.On the day of the reported incident, the tempus pro was running from the battery and not connected to mains.In between cycles, the battery was either charged or swapped out from the device.Swapping between batteries could have led to incorrect fitting of the battery which may have caused the loss of power.The device was returned for investigation and power cycled the tempus 100 times and tested with medical parameters for 2 weeks.The device functions are working correctly and no defects were found.No fault could be identified for the cause of the reset.The most likely cause would have been an incorrect battery fitting to the device.The tempus pro is performing to specification and is to be returned to the customer.

• 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: 15318874
• MDR Text Key: 303631596
• Report Number: 3003832357-2022-00021
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 11/04/2022
• 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