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

Model Number 00-1024-R

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2022

Event Type  malfunction  

Event Description

As described by the customer device shut down while in the cradle monitoring the patient.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

This report is based on information provided by philips repair service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that the device shuts down while in the cradle monitoring the patient.The service engineer investigation the device and confirmed reported complaint unconfirmed, the unit is working correctly at the bench.Logs are being pulled for rdt to evaluate.Customer confirmed that the docking station on site was the issue, once the docking station was replaced issues no longer occurred.Calibrated nbp and co2.Device functions are working correctly.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 (RDT); ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• Manufacturer (Section G): REMOTE DIAGNOSTIC TECHNOLOGIES (RDT); ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• Manufacturer Contact: rekha rv ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 15759428
• MDR Text Key: 304894110
• Report Number: 3003832357-2022-00045
• 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: 10/10/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 03/28/2023
• 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: Reuse
• Patient Sequence Number: 1