FDA Adverse Event
Death
Summary report: N
TEMPUS LS
MDR report key: 19897742
·
Received August 2, 2024
Report
- Report Number
- 3003832357-2024-00591
- Event Type
- Death
- Date Received
- August 2, 2024
- Date of Event
- July 28, 2024
- Report Date
- December 11, 2024
- Manufacturer
- SCHILLER AG
- Product Code
- LDD
- UDI-DI
- 07613365002737
- PMA / PMN Number
- K200849
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT WAS REPORTED WHEN WORKING A CARDIAC ARREST EVENT, THE DEVICE MALFUNCTIONED AND STARTED READING HARDWARE FAILURE (DPM). THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. A PATIENT DEATH WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1037531 | TEMPUS LS | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3020 | 07613365002737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |