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

Catalog Number 453564842181

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Cardiac Arrest (1762)

Event Date 12/29/2022

Event Type  Injury  

Event Description

The customer reported failing to deliver defibrillation during a cardiac arrest.The unit read pads on/pads off several times and would not show a rhythm.Crews replaced pads and were finally able to deliver a shock to the patient.A user report was received related to a reported product problem which is currently being investigated.Further updates will be provided when 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 GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 16232341
• MDR Text Key: 307987341
• Report Number: 3003832357-2023-00020
• 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: 01/24/2023
• 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
• Date Manufacturer Received: 12/29/2022
• 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