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

Model Number 00-1026-R

Device Problem No Flow (2991)

Patient Problem Unspecified Heart Problem (4454)

Event Date 09/14/2023

Event Type  malfunction  

Event Description

This report is based on information provided by a philips technical support and a philips remote service engineer and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that the capnography is defective.While the device was noted to be in use, there was reportedly no patient or user harm or impact.

Manufacturer Narrative

Remote service determined the device would require return for repair.It was returned to a philips bench repair facility and after testing the error message "check sample line blocked" was displayed which is related to the return flow (the flow of the gas out of the device).A gas sample is collected from the patient, passes through the sample line, the gas module analyzes the sample and expels the flow out of the device.The gas was not flowing out of the device.The device was dismantled and the root cause was determined to be the overlapping of the pipes and data cables of the capnometer module, which caused a settling of the expiratory flow line resulting in the pump to fail.The pipes and data cables were reorganized to prevent overlap and movement of the flow pipes during use of the device.Testing and verification was completed satisfactorily and the device was returned to service at the customer site.Based on the information available and testing conducted, the cause of the reported problem was overlapping of the pipes and data cables.The reported problem was confirmed.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 that while no harm was alleged, recurrence of this failure mode during clinical use could cause or contribute to death or serious injury.Therefore, this failure mode meets the definition of a reportable malfunction.Appropriate regulatory reporting actions have been taken.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 adjustments were completed.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 PATIENT MONITOR, WTIH PRINTER AND IBP 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: 17839480
• MDR Text Key: 324531052
• Report Number: 3003832357-2023-00678
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472441058
• UDI-Public: 05060472441058
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/14/2023
• 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