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

Model Number 00-3020

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2022

Event Type  Death  

Event Description

The complaint as described by the customer - i ran run #220039209 which was a cardiac arrest.Patient went in to vfib and i was able to successfully defibrillate the patient.At the next pulse check patient was found in vtach without a pulse.The monitor charged but when i hit the button to deliver the shock, an error message came across the screen stating the shock was not delivered due to an internal malfunction.I attempted to shock again and received the same message.I attempted to deliver the shock four times after the first shock and i got a malfunction error all four times.The initial shock delivered without a problem." the manufacturer (schiller) reviewed the log files.The investigation of the log files showed that after the first successful shock delivery the device always discharged the shock internally due to failure 6.Why the device was not able to deliver another shock after the first successful shock is not clear now.The indicated error (int.Discharge 6) is displayed if the measured patient current is 0a or greater than 105a during shock delivery.During a self-test, the shock delivery to a patient (or simulator) is not checked.Therefore, the device must also be checked for shock delivery before daily use.Which was not done with this device (there is only the automatic self test and the intervention, the device was not started for the daily test by the user).

Manufacturer Narrative

A user report was received related to a reported patient death 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

The complaint as described by the customer - i ran run #(b)(4) which was a cardiac arrest.Patient went in to vfib and i was able to successfully defibrillate the patient.At the next pulse check patient was found in vtach without a pulse.The monitor charged but when i hit the button to deliver the shock, an error message came across the screen stating the shock was not delivered due to an internal malfunction.I attempted to shock again and received the same message.I attempted to deliver the shock four times after the first shock and i got a malfunction error all four times.The initial shock delivered without a problem." the manufacturer (schiller) reviewed the log files.The investigation of the log files showed that after the first successful shock delivery the device always discharged the shock internally due to failure 6.Why the device was not able to deliver another shock after the first successful shock is not clear now.The indicated error (int.Discharge 6) is displayed if the measured patient current is 0a or greater than 105a during shock delivery.During a self-test, the shock delivery to a patient (or simulator) is not checked.Therefore, the device must also be checked for shock delivery before daily use.Which was not done with this device (there is only the automatic self test and the intervention, the device was not started for the daily test by the user).The investigation of the logfile showed that after the first successful shock delivery the device always discharged the shock internally due to failure 6 the device returned on 10th june 2022 and investigated by the manufacturer schiller.Incoming inspection and additional tests were performed at customer service department on 14 june 2022.The device was checked without any problems during the incoming inspection.The firmware was already on version 1.3.5.The pacer worked normally at all currents and frequencies.The device was tested further at r&d on 15th of june 2022.No error could be detected, shock delivery was possible.So the cause cannot be evaluated.The device functioned as intended.The failure could not be reproduced.

• 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: selvaganesan balu ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 14470262
• MDR Text Key: 292375335
• Report Number: 3003832357-2022-00003
• 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
• 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?: No
• Device Operator: Health Professional
• Device Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• 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): Death