FDA Adverse Event
Death
Summary report: N
TEMPUS LS - MANUAL
MDR report key: 19070767
·
Received April 9, 2024
Report
- Report Number
- 3003832357-2024-00297
- Event Type
- Death
- Date Received
- April 9, 2024
- Date of Event
- November 29, 2023
- Report Date
- June 26, 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
- WI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT THE LS UNIT FAILED TO RECOGNIZE THE ATTACHED DEFIB PADS. THE LS UNIT SIMPLY FAILED TO WORK DURING A CARDIAC ARREST. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT THE LS UNIT FAILED TO RECOGNIZE THE ATTACHED DEFIB PADS. THE LS UNIT SIMPLY FAILED TO WORK DURING A CARDIAC ARREST. A PATIENT DEATH WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608191 | TEMPUS LS - MANUAL | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3020 | 07613365002737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male | Death |