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

Model Number 00-3020

Device Problems Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Customer reports they were transporting patient from hospital to another facility and attempted to pace a 80 yo bradycardic patient with a hr between 30-40 and device would not pace patient, displayed message "hardware failure dpm" the current was 45ma.Customer retrieved another tempus ls device and was able to pace patient for the remainder of the trip to receiving facility.The log files of the device was analysed by the manufacturer (schiller).It shows that the pacer started several times but always stopped.The "hardware failure (dpm)¿ was displayed to the user.This event seems to be a known issue "pacer error 26" which is non-reproducible and is under trending and internal investigation with the dedicated sagqi-137 ((b)(4)) - tempus ls: pacer issues.

Event Description

Customer reported pacing failure during use on a patient; pacing was attempted but stopped by the device and a "dpm hardware failure" message appeared.Customer reported they were transporting patient from hospital to another facility and attempted to pace an 80 ma bradycardic patient with an hr between 30-40 and device would not pace the patient, displayed message "hardware failure dpm" the current was 45ma.Customer retrieved another tempus ls device and was able to pace patient for the remainder of the trip to receiving facility.As per business strategy, the customer was issued with a replacement tempus ls.The log and rescue files were requested from the customer and sent to schiller manufacturer.Schiller(manufacturer) analysed the log files and determined that the pacer always stopped due to "error 26".The trigger and actual root cause of this error and failure mode has not been concluded at this stage, however, this is a known non-reproducible issue and is being addressed by schiller via trending and internal investigation under capa 0029 - 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: 14498021
• MDR Text Key: 300464047
• Report Number: 3003832357-2022-00006
• 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: K20849
• 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

• 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?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2020
• 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: 80 YR