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 No Device Output (1435); Failure to Power Up (1476)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

It has been reported to philips that tempus pro system failure upon start up.A user report was received related to a reported product problem which is currently being investigated.Further updates will be provided when the investigation is completed.

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 that the system failed to start up.Diagnostics determined the device would require return for repair and it was returned to a philips bench repair facility where the reported complaint was confirmed as the device would not re-boot.On internal inspection it was observed that the trizeps board was dislodged from the sbc (single board computer).Once the trizeps was reseated the device functioned correctly.Testing and verification was completed satisfactorily (calibrated nbp, co2 and touch screen) and the device was returned to service at the customer site.No parts required device functions are working correctly.Based on the information available and testing conducted, the cause of the reported problem was the trizeps board becoming dislodged.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 the engineering activity.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: 16645357
• MDR Text Key: 312420453
• Report Number: 3003832357-2023-00173
• 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

• Date FDA Received: 03/30/2023
• 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
• Date Manufacturer Received: 03/15/2023
• 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