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

Catalog Number 453564842181

Device Problems Unable to Obtain Readings (1516); Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Arrest (1762)

Event Date 10/28/2022

Event Type  Death  

Event Description

The customer reported tempus ls stopped ecg rhythm during cardiac arrest was treated.The ls monitor was turned on and pads were applied to the patient.After a minute, the ls was not reading any rhythm.The screen looked as if nothing was attached to the monitor.(looked like the initial screen when you turn the monitor on) after a couple of attempts in switching the pads, the result stood the same.The patient was expired.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 the investigation is in progress.

Event Description

Updated the type of complaint from product problem to death.However, it is already mentioned and submitted in the initial report.

Manufacturer Narrative

Updated report to accurately reflect death.

• 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: tanya deschmidt ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15879461
• MDR Text Key: 304894257
• Report Number: 3003832357-2022-00054
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 02/03/2023
• 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): Death
• Patient Age: 30 YR
• Patient Sex: Female