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

Model Number 00-1024-R

Device Problems Incorrect Measurement (1383); Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 01/05/2023

Event Type  Death  

Event Description

The customer reported the device showed 2 different rhythms between pro and ls during a cardiac arrest while synced.The patient was pronounced dead at emergency room.Witnessed cardiac arrest on patient arrival, rhythm assessment showed v-fib on pro monitor and asystole on the ls.The defibrillated and the monitor still showed v-fib while asystole on ls.The pr (b)(4) was submitted for the complaint related to ls.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 in progress.

Manufacturer Narrative

The complaint was escalated for technical investigation and the results indicate that complaint for tempus pro is not confirmed.The unit has been tested the logs have been evaluated and all functions with the ecg and otherwise are working correctly.No parts are required.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.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: 16320730
• MDR Text Key: 309012941
• Report Number: 3003832357-2023-00034
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 01/09/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 08/11/2023
• 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): Death
• Patient Age: 50 YR
• Patient Sex: Female