MAUDE Adverse Event Report: SCHILLER AG TEMPUS LS; LOW ENERGY DEFIBRILLATOR

Model Number 00-3020

Device Problems Failure of Device to Self-Test (2937); No Pacing (3268)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported the device came up with error message internal discharge def failure.There was no patient involvement.

Manufacturer Narrative

This report is based on information provided by a philips field service engineer and schiller (equipment manufacturer) and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls manual indicating that the device failed pacing with the error message internal discharge def failure.A replacement device was sent to the customer.The log and rescue files and the device were received at schiller where a technical investigation was completed.Error 26 'pace error' was observed on the log file.Schiller has identified that the defibrillator/pacemaker module (dpm) may encounter an issue where communication from the device mainboard and the dpm board fails.In this event, the device will halt pacing and an error message will be displayed 'dpm hardware failure'.Schiller concluded that the issue is not clearly reproducible, the exact root cause cannot be determined.However, taking all components into account which are part of the communication path between the dpm board and the mainboard, and which may cause an intermittent loss of communication, the source of the issue is most likely to be of a mechanical nature such as a connector.The returned device was removed from service and processed following local procedures.Based on the information available and the testing conducted, the cause of the reported problem cannot be determined however the likely cause is the board-to-board connector between the dpm board and the mainboard.The reported problem was confirmed.Based on the information available and results of additional analysis further action has been initiated.The customer was provided a replacement device to resolve the issue.It has been concluded that no further action is required at this time.

• Brand Name: TEMPUS LS
• Type of Device: LOW ENERGY DEFIBRILLATOR
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer (Section G): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer Contact: tanya deschmidt ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 17620669
• MDR Text Key: 322485555
• Report Number: 3003832357-2023-00565
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• UDI-Public: 07613365002737
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• 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: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 01/16/2024
• 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