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

Model Number 00-1026-R

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 11/25/2022

Event Type  malfunction  

Event Description

The fault reported was that the device only boots as far as the blue start-up screen however workshop testing seems to show that the unit progresses past the blue rdt screen but then the screen goes blank, the green light on the on/off button continuously flashed but the unit does nothing else.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 the investigation is in progress.

Manufacturer Narrative

The problem was detected after when the device was received back from the repair.Workshop testing seems to show that the unit progresses past the blue rdt screen but then the screen goes blank.Philips received a complaint on the tempus pro indicating that the device only boots as far as the blue start-up screen.Problem detected after when the device was received back from the repair.Workshop testing seems to show that the unit progresses past the blue rdt screen but then the screen goes blank.The complaint was escalated to technical investigation and the results indicate that trizeps board became unseated.The earlier (previous repair) fitted h-frame had no secure fit.The h-frame has been replaced with a newer version (black).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.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.

Event Description

This report is based on information provided by philips repair service quest international personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that the device only boots as far as the blue start-up screen.

Manufacturer Narrative

Updated problem code and conclusion code.

Event Description

This report is based on information provided by philips repair service quest international personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that the device only boots as far as the blue start-up screen.

• 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: 16035499
• MDR Text Key: 306011049
• Report Number: 3003832357-2022-00067
• Device Sequence Number: 1
• Product Code: MHX
• 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,Followup,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-1026-R
• Device Catalogue Number: 989706000101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other