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

Model Number 00-3020

Device Problems Pacing Problem (1439); No Pacing (3268)

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

Event Date 02/20/2023

Event Type  Injury  

Event Description

It has been reported to philips that pacing failure in tempus ls.

Manufacturer Narrative

This report is based on information provided by philips repair service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that the device failed to pace.The pacer would start and let met up the current, but then it stopped and on the screen hardware error appeared.User tried multiple times to get the pacer to start and it keep giving the pacing error.The user unplugged the 4 lead cables from the monitor and to make sure it was not the cables but the same error appeared.After multiple times of trying to get the pacer work the user decided to stop.The log files were provided to manufacturer schiller.However, the file provided is corrupted and cannot be read.The investigation performed when the device arrived to schiller.The device has been confirmed with error message "dpm hardware failure" / error 26.As 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.Therefore, it is suspected that the board-to-board connector between the dpm-board and the mainboard may be the root cause for this issue.As the root cause cannot be verified, schiller cannot come to a conclusion.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.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: 16591496
• MDR Text Key: 311770249
• Report Number: 3003832357-2023-00128
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• UDI-Public: 7613365002737
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• 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: 02/20/2023
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 41 KG