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

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

As described by the customer 'when the ems crew were using the video laryngoscope to intubate the patient, when they used the "image capture" feature the tempus pro device immediately "shut down"'.Crew had to restart the device to continue to monitor patient with the device until arrival at the hospital.The customer reports the video laryngoscope was not unplugged from the usb port.A user report was received related to a reported product problem which is currently being investigated.At the time of reporting, the device has been returned for investigation.Further updates will be provided when the device investigation has progressed.

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 tempus pro - monitor shut down when using video laryngoscope "image capture" when intubating their patient.Customer confirmed was not unplugged from the usb port.The complaint was escalated for technical investigation and the results indicate that after event device passes startup self test.No error messages were displayed and no warning messages was given prior to shut down.No patient harm noted.At the bench: engineer 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 (b)(6) photos can overwhelm the device and require a restart.This failure mode was escalated to r&d for additional investigation.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 (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: selvaganesan balu ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 15604230
• MDR Text Key: 303629595
• Report Number: 3003832357-2022-00032
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 05/15/2023
• 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
• Patient Outcome(s): Other