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 Computer Software Problem (1112); Appropriate Term/Code Not Available (3191)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

As described by the customer device shuts down low c-max use.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.

Event Description

As described by the customer device shuts down low c-max use.A user report was received related to a reported product problem which was investigated and found no defect with the device.The device nbp and co2 were calibrated and returned the device to the customer with full functionality.

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 device shuts down c-max use.Confirmed complaint the unit will restart when there are a large number of photos are taken with the use of a video laryngoscope as few as 10 photos can overwhelm the device and require a restart.There is no repair for this function required per rdts evaluation.This failure mode was escalated to r&d for additional investigation and capa is in progress.The primary root cause was identified as inadequate software verification and validation.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 investigation concludes that no further action is required at this time.

• 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: jon yard ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15750891
• MDR Text Key: 303632116
• Report Number: 3003832357-2022-00039
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472441058
• UDI-Public: 05060472441058
• 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,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: 00-1026-R
• Device Catalogue Number: 989706000101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 12/06/2022; 12/06/2022
• Supplement Dates FDA Received: 12/08/2022; 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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