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

Model Number 00-3020

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Arrest (1762)

Event Date 10/15/2022

Event Type  Injury  

Event Description

The customer reported during the resuscitation of a cardiac arrest patient, the tempus ls failed to provide an ecg tracing via the defibrillator electrodes.Providers on scene attempted to deploy a total of 3 defibrillator electrodes across two tempus ls devices without success.Troubleshooting efforts were unsuccessful and ultimately the cardiac arrest had to be managed with an aed (automated external defibrillator).It was noted after the call that all defibrillator electrodes were from the same lot number.Analysis of the data following the call revealed multiple messages in the monitor indicating "pads attached" and "pads detached" in rapid sequence.At times these messages were occurring 3-4 times a second.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.

• 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 ; UK
• MDR Report Key: 15879634
• MDR Text Key: 304459814
• Report Number: 3003832357-2022-00055
• 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

• Date FDA Received: 11/29/2022
• 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
• Device Lot Number: Y110821-05
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/31/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening