MAUDE Adverse Event Report: REMOTE DIAGNOSTIC TECHNOLOGIES LTD. TEMPUS PRO; REMOTE DIAGNOSTIC TECHNOLOGIES LTD.

Model Number 00-1024-R

Device Problems Display or Visual Feedback Problem (1184); Device Handling Problem (3265); Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2022

Event Type  malfunction  

Event Description

It was reported to philips that tempus pro has a damaged display.

• Brand Name: TEMPUS PRO
• Type of Device: REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
• 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: shannon decker ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 16817338
• MDR Text Key: 314040472
• Report Number: 3003832357-2023-00246
• 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: Health Professional
• 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 Number: 00-1024-R
• Device Catalogue Number: 989706000051
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 04/26/2023
• 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