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

Model Number 00-1024-R

Device Problems Application Program Version or Upgrade Problem (2881); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

As described by the customer 'error message displayed during patient care; unit froze up (no patient/user was harmed)'.Rdt startup sbcdll not loaded error message displayed/device froze when selecting 12 lead ecg while monitoring patient.A user report was received related to a reported product problem which is currently being investigated.At the time of reporting, the device has not yet been returned for investigation.Further updates will be provided when the device is received and investigation has progressed.

Event Description

As described by the customer 'error message displayed during patient care; unit froze up (no patient/user was harmed)'.Rdt startup sbcdll not loaded error message displayed/device froze when selecting 12 lead ecg while monitoring patient.The service engineer confirmed the reported complaint that the unit will freeze when trying to get a 12-lead reading.To correct this issue engineer reloaded software and confirmed firmware rev is up to date.Power cycled the device 20 times to ensure the function of ecg 12-lead is restored.Calibrated nbp and co2.Confirmed device functions are working correctly.The service report is attached.

• 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: rekha rv ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15604219
• MDR Text Key: 303629679
• Report Number: 3003832357-2022-00031
• 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: 09/16/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 02/01/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 54 KG