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

Model Number 00-1007-R

Device Problems Image Display Error/Artifact (1304); Appropriate Term/Code Not Available (3191)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

The customer reported ecg artifact on 5 leads ecg cable.A user report was received related to a reported product problem which is currently being investigated.At the time of reporting, the cable 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

Diagnostic performed by engineer that 5 lead cable was defective and gives very noisy signal.Device had been tested with known working 5lead cable and tests was ok.12ld has been tasted additionally and confirmed cable was working.Other parameters tested in the device and they are within specifications.Based on the information available and the testing conducted, the cause of the reported problem was confirmed.Cable has been replaced for the customer.The device was operational after the cable was replaced.The investigation concludes that no further action is required at this time.

Event Description

This report is based on information provided by a philips repair service engineer and has been investigated.Philips received a complaint on the tempus pro indicating 5 lead ecg cable isn't working.Problem detected during the preventive maintenance.

Manufacturer Narrative

Investigation summary updated - this report is based on information provided by philips repair service quest international.And has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating 5 lead ecg cable isn't working.Problem detected during the preventive maintenance.The complaint was escalated for technical investigation and the results indicate that 5ld ecg cable determined defective.Cable has been replaced for the customer.Full test and verification and calibration completed - all passed within specification.Based on the information available and results of additional analysis, no further action is necessary at this time.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 cable was replaced.The investigation concludes that no further action is required at this time.

Event Description

This report is based on information provided by a philips repair service engineer and has been investigated.Philips received a complaint on the tempus pro indicating 5 lead ecg cable isn't working.Problem detected during the preventive maintenance.

• 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: 16036354
• MDR Text Key: 306108632
• Report Number: 3003832357-2022-00077
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472440013
• UDI-Public: 05060472440013
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K201746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• 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: 00-1007-R
• Device Catalogue Number: 989706000001
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 11/22/2022; 11/22/2022
• Supplement Dates FDA Received: 02/14/2023; 07/21/2023
• 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