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

Model Number 00-3020

Device Problem No Pacing (3268)

Patient Problems Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2023

Event Type  Injury  

Event Description

It has been reported to philips that tempus ls has dpm faults.A user report was received related to a reported product problem which is currently being investigated.Further updates will be provided when the investigation is completed.

Manufacturer Narrative

The type of reported complaint has been updated from product problem to serious injury.

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 a dmp fault (unable to pace).While the device was noted to be in use, there was reportedly no patient or user harm or impact however failure to shock/pace is considered a serious injury due to a serious deterioration of health that may result from a delay or failure to shock/pace.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 main board 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 main board, 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 main board.The reported problem was confirmed.Based on the information available and results of additional analysis further action has been initiated.A review of the risk management file was performed by the equipment manufacturer, schiller.Tempus ls risk analysis- schiller qms, version 27 and tempus ls risk management plan - tempus ls - schiller qms, version 13 were referred to when the decision was made to make the event reportable.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 customer was provided a replacement device 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 LS-MANUAL
• 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: 17780111
• MDR Text Key: 323813100
• Report Number: 3003832357-2023-00610
• Device Sequence Number: 1
• Product Code: LDD
• 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
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Date Manufacturer Received: 08/22/2023
• 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
• Patient Outcome(s): Other