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

Catalog Number 989706000051

Device Problems Loose or Intermittent Connection (1371); Unexpected Shutdown (4019)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  Death  

Event Description

It was reported to philips that the video laryngoscope had a fault while treating, the screen went out and restart was required.This issue may has contributed to patient's death.Further information will be send upon completion of the manufacturer's investigation.

Manufacturer Narrative

20sept2023 dp: this report is based on information provided by a philips remote service engineer, and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro patient monitor indicating that the device screen went out and restart was required.This was when the video laryngoscopy was in use during intervention.It was alleged that the issue may have contributed to patients death.Event date: 8/14/2023.Remote service engineer has identified the device as within the scope of the fsn-2023-cc-ec-005.Customer advised to complete form as sw correction will be sent to customer when it is available.Based on the information available the reported problem was confirmed.A review of the risk management file was performed, and the potential severity is s1 has been identified in the risk document.A clinical harm review was performed.This event was assessed as  related to a product problem with the device.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 device is back into service with the limitations described in fsn-2023-cc-ec-005.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Patient outcome and evaluation method code was updated.

• 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: 17825872
• MDR Text Key: 324372506
• Report Number: 3003832357-2023-00670
• 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,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 Catalogue Number: 989706000051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 08/29/2023; 08/29/2023
• Supplement Dates FDA Received: 10/16/2023; 02/16/2024
• 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: 84 YR
• Patient Sex: Male