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

Model Number 00-3020

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/03/2022

Event Type  Injury  

Event Description

Assistant chief stated the emts attempted to utilize device for demand pacing of a patient who was bradycardic/peri-arrest.Pacer failed and presented with "hardware failure" error message on screen.Device turned off and back on and issue persisted.They used a different device to pace the patient and continued using the different monitor successfully on the patient.A user report was received related to a reported product problem which was investigated by schiller.Schiller(manufacturer) analysed the log files and determined that the pacer always stopped due to "error 26".At this stage it is not known whether this issue is intermittent or persistent on this device.However, it is suspected that the error is caused due to communication issue to the dpm board is being addressed by schiller via trending and internal investigation.This error is under observation in sagqi-137 (capa(b)(4)) - tempus ls: pacer issues.

• 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: rekha rv ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 16120308
• MDR Text Key: 306881010
• Report Number: 3003832357-2023-00013
• 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

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 Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 01/09/2023
• 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