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

Model Number 00-1024-R

Device Problem Failure to Analyze Signal (1539)

Patient Problem Unspecified Heart Problem (4454)

Event Date 04/21/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the device is not reading the 12 led correctly.There are no consequences to the patient.

Manufacturer Narrative

Initial diagnostics determined that the device was required to be returned to the bench for investigation.The device was returned to a philips bench repair facility and where the device and the units ecg functions were working satisfactorily however physical damage was observed on the front case requiring replacement.This was not related to the reported malfunction and was investigated and the device repaired (refer to (b)(4).Testing and verification on the device was completed satisfactorily and the device was returned to service at the customer site.Further investigation of this reported malfunction found the issue to be associated with the mounted cradle (serial number (b)(6) where replacement would be followed up with the relevant sales representative.Based on the information available and testing conducted, the cause of the reported problem was the mounted cradle the reported problem with the device was not confirmed.Based on the information available, no further action is necessary at this time.A review of the risk management file was performed, and the severity of this complaint is considered s0, the potential severity of s2 was identified in the risk document.The device was confirmed to be operating per specifications and no failure was identified.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: jon yard ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 16987983
• MDR Text Key: 316432382
• Report Number: 3003832357-2023-00327
• 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: 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: 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: 05/08/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/28/2023
• 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 Age: 84 YR
• Patient Sex: Female