FDA Adverse Event
Injury
Summary report: N
TEMPUS LS-MANUAL
MDR report key: 17548815
·
Received August 15, 2023
Report
- Report Number
- 3003832357-2023-00531
- Event Type
- Injury
- Date Received
- August 15, 2023
- Date of Event
- August 1, 2023
- Report Date
- August 15, 2023
- 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
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THAT TEMPUS LS DEFIBRILLATING WITHOUT PROMPTING. 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 COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1736842 | TEMPUS LS-MANUAL | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3020 | 07613365002737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |