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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported to philips that the ecg monitoring display was not working properly during patient care.The cables were initially replaced, and it has still reported errors in the coming days.Troubleshooting the monitor could not duplicate the error but all 3 shifts reported the same issues with the device.Operators were paramedics, no harm or injuries occurred to patients.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 philips field service engineer and bench service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that ecg monitoring was not displaying.While the device was noted to be in use, there was reportedly no patient or user harm or impact.The device was returned to a philips bench repair facility and diagnostics could not confirm the complaint as the device was functioning satisfactorily therefore the log files required evaluation.The log files were evaluated by a philips product support specialist at the bench repair facility and the logs indicted a fault with the cable and not the tempus pro device.The nbp, co2 and touch screen were calibrated and no parts were required, the device was returned to service at the customer site.Based on the information available and the testing conducted, the cause of the reported problem was the ecg cable.The reported problem was confirmed although no problem was identified with the tempus pro device.Based on the information available, no further action is necessary at this time.An analysis was performed by a vigilance reporting specialist (vrs).The vrs determined recurrence of this failure mode during clinical use could cause treatment delays.Therefore, this event is considered to be an adverse event due to the serious deterioration in the state of health of the patient because live-saving therapy/treatment has been interrupted and or delayed.Therefore, this failure mode meets the definition of a reportable malfunction.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 confirmed to be operating per specifications and no failure was identified.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: 17397491
• MDR Text Key: 320141386
• Report Number: 3003832357-2023-00487
• 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: 07/03/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 10/19/2023
• 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