MAUDE Adverse Event Report: SCHILLER AG TEMPUS LS; DEFIBRILLATOR

Model Number 00-3020

Device Problem Pacing Problem (1439)

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 would not pace during a training class.There was no patient involvement.

Manufacturer Narrative

This report is based on information provided by a philips field service engineer and schiller (manufacturer) and has been investigated by the philips complaint handling team.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 was observed on the log file due to loss of communication most likely due to a hardware failure.Schiller has identified that the defibrillator/pacemaker module (dpm) may encounter an issue where communication from the device mainboard and the dpm board fails.The device was removed from service at schiller.Based on the information available and the testing conducted, the cause of the reported problem was a communication error from the main board to the dpm module, error 26 was observed on the logfile.The reported problem was confirmed.A replacement device was provided.The investigation concludes that no further action is required at this time.

• Brand Name: TEMPUS LS
• Type of Device: 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: 17620561
• MDR Text Key: 321949040
• Report Number: 3003832357-2023-00563
• 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

• Date FDA Received: 08/24/2023
• 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
• Date Manufacturer Received: 07/26/2023
• 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