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

Model Number 00-1024-R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

As described by the customer 'will not boot up and powered down while on a patient'.Device returned to the service bench for the initial evaluation and upon internal inspection, the trizeps board is not seated correctly causing the device to not boot.Once the trizeps was seated correctly the device functions all worked correctly.Calibrated nbp and co2.This failure is under monitoring for further trending and root cause investigation.

• Brand Name: TEMPUS PRO
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): REMOTE DIAGNOSTIC TECHNOLOGIES (RDT); ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• Manufacturer (Section G): REMOTE DIAGNOSTIC TECHNOLOGIES (RDT); ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• Manufacturer Contact: selvaganesan balu ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 15409550
• MDR Text Key: 303431297
• Report Number: 3003832357-2022-00028
• 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

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/13/2022
• 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
• Patient Outcome(s): Other