FDA Adverse Event Death Summary report: N

TEMPUS LS-MANUAL

MDR report key: 20189653 · Received September 11, 2024

Report

Report Number
3003832357-2024-00676
Event Type
Death
Date Received
September 11, 2024
Date of Event
September 5, 2024
Report Date
November 22, 2024
Manufacturer
SCHILLER AG
Product Code
LDD
UDI-DI
07613365002737
PMA / PMN Number
K200849
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
OTHER
Health Professional
N

Narratives

Description of Event or Problem · 0

IT WAS REPORTED TO PHILIPS THAT THE CREW WAS ATTEMPTING TO PACE A PATIENT AND KEPT GETTING A "PACER ERROR" WHEN TRYING TO PACE THE PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
564192 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Death