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

Model Number 00-1007

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Type  malfunction  

Event Description

It has been reported to philips that after software update, an crc error with one or more configuration files occurred.No patient involvement.

Manufacturer Narrative

The customer was advised by a philips technician to reload the software then import the configuration files.The customer reported that this resolved the issue.The device was returned to full functionality.No further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was an issue with the software update.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The customer reloaded the software and imported the configuration files to resolve 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
• 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: 17232638
• MDR Text Key: 318209661
• Report Number: 3003832357-2023-00423
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472440655
• UDI-Public: 05060472440655
• 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: Health Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 00-1007
• Device Catalogue Number: 989706012250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 02/01/2024
• 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