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

Model Number 00-1024-R

Device Problem Calibration Problem (2890)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the tempus pro touchscreen is out of calibration.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer and a bench engineer and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating the touch screen issue.Diagnostics determined the device would require return for repair and it was returned to a philips bench repair facility.The reported complaint was confirmed as the unit touch screen is out to calibration.The display assembly (rdt display assembly kit, part number 453564842111) was replaced resolving the customer¿s complaint.Testing and verification were completed satisfactorily (calibrated nbp, co2, and touch screen) and the device was returned to service at the customer site.Based on the information available and testing conducted, the cause of the reported problem was a defective display.The reported problem was confirmed.Based on the information available, no further action is necessary at this time.While no harm was alleged, recurrence of this failure mode during clinical use could cause or contribute to death or serious injury.Therefore, this failure mode meets the definition of a reportable malfunction.Appropriate regulatory reporting actions have been taken.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.If additional information is received the complaint file will be reopened.

• 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: 17450929
• MDR Text Key: 320349105
• Report Number: 3003832357-2023-00515
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 01/30/2024
• 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