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

Model Number 00-3020

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

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

Event Date 10/03/2022

Event Type  Injury  

Event Description

As described by assistant chief states the emt's attempted to utilize the device for demand pacing of 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.Pads also kept reading as "check electrodes" even though they properly adhered to the patient's skin.A user report was received related to a reported product problem which is currently being investigated.At the time of reporting, the device has not yet been returned for investigation.Further updates will be provided when the device is received and investigation has progressed.

Event Description

As described by assistant chief states the emt's attempted to utilize the device for demand pacing of 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.Pads also kept reading as "check electrodes" even though they properly adhered to the patient's skin.A user report was received related to a reported product problem which was investigated by schiller (manufacturer).The logfiles provided by the customer were investigated at schiller ag and the investigation on the logfile showed the occurrence of several "error 26" - dpm hardware failure.This issue appears to be a non-reproducible pacer error, which is logged as error 26 in the logfile.As the error is not reproducible, the root cause cant be concluded.However, it is suspected that the error is caused due to communication issue to the dpm board.This error is under observation in sagqi-137 (capa-0029) - tempus ls: pacer issues.

• Brand Name: TEMPUS LS-MANUAL
• Type of Device: LOW ENERGY DEBFIBRILLATOR
• 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: 15716807
• MDR Text Key: 302875172
• Report Number: 3003832357-2022-00034
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-3020
• Device Catalogue Number: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• 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