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

Model Number 00-1007-R

Device Problem Display Difficult to Read (1181)

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

Event Date 07/27/2022

Event Type  malfunction  

Event Description

Philips received a complaint on the tempus pro indicating that screen resolution has gone dark on one side and light on the other.The device was returned to philips for evaluation and tested for functionality.The fault was confirmed by an engineer and to address the issue display was replaced (rainbow front case).The engineer confirmed screen works correctly, based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.

• 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 Key: 17508425
• MDR Text Key: 321181839
• Report Number: 3003832357-2023-00526
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472440013
• UDI-Public: 05060472440013
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/11/2023

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: 00-1007-R
• Device Catalogue Number: 989706000001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other