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

Model Number 00-1026-R

Device Problem Device Sensing Problem (2917)

Patient Problem Unspecified Heart Problem (4454)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

This report is based on information provided by remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating ecg artifacts.

Manufacturer Narrative

The assigned field service engineer (fse) was able to duplicate the event and noted that it was intermittent.The fse attributed ecg environmental interferences caused, mainly, by the ambulance inverter.No malfunction of the tempus pro was observed, the device is fully functional.Philips conducted a technical investigation of the customer's site and the ambulance manufacturer to further elucidate the source of the electromagnetic (emc) noise.The fse provided the customer with best practices for use.The reported problem was confirmed.Based on information obtained from site visits and device testing through recreation of similar emc noise environments, the customer was advised on equipment upgrades, adjustments to filtering settings, and improvements to ecg techniques.Based on the information available and results of additional analysis further action has been initiated.A review of the risk management file was performed, and the potential severity is s2 has been identified in the risk document.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 customer was provided with recommendations on how to address the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: TEMPUS PRO PATIENT MONITOR, WITH PRINTER OPTION
• 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: 17836703
• MDR Text Key: 324509542
• Report Number: 3003832357-2023-00677
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472441058
• UDI-Public: 05060472441058
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K201746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 09/28/2023
• 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