FDA Adverse Event
Death
Summary report: N
TEMPUS LS-MANUAL
MDR report key: 16302658
·
Received February 6, 2023
Report
- Report Number
- 3003832357-2023-00025
- Event Type
- Death
- Date Received
- February 6, 2023
- Date of Event
- January 5, 2023
- Manufacturer
- SCHILLER AG
- Product Code
- LDD
- UDI-DI
- 07613365002737
- PMA / PMN Number
- K200849
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
EVENT DATE UPDATED TO 05JAN2024.
Description of Event or Problem · 0
THE BIOMED REPORTED LS WENT INTO SELF TEST DURING ACTIVE USE. AFTER DELAY, THE LS WAS CHARGED TO J SETTING NEEDED BUT WOULDN'T DELIVER SHOCK. CHARGED J SETTINGS WERE ILLUMINATED RED NOT ORANGE AND WOULD NOT DUMP THE CHARGE. THE CARDIAC ARREST PATIENT WAS EXPIRED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1226368 | TEMPUS LS-MANUAL | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3020 | 07613365002737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Death |