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

Model Number 00-1007-R

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

It has been reported to philips that brent palmer from medaire, is onboard a yacht (my quartz) setting up their new tempus als machine.They do seem to have an issue with the ultrasound probes, they are disconnecting and reconnecting many times.The slightest movement of the cable seems to upset them, and four or five disconnects in a row, the unit just will not read that a probe is connected.I think it is either software or the probes themselves, as the laryngoscope works without an issue.Have you encouraged this issue before and if so what is the fix? currently it is impossible to take a scan.¿ i cannot get the tempus and ls to pair failed to connect with tempus ls tempus pro and tempus ls may not be authenticated correctly.(b)(6).Bhsc (nursing).Director education and strategic customer relations.Medaire, an international sos company.Mobile: (b)(6).E-mail: (b)(6).Best contact onboard: either of the nurses (b)(6).

• 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: 17210767
• MDR Text Key: 318131034
• Report Number: 3003832357-2023-00412
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 05060472440013
• UDI-Public: 05060472440013
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 00-1007-R
• Device Catalogue Number: 989706000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 04/05/2024
• 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