FDA Adverse Event
Injury
Summary report: N
TEMPUS LS-MANUAL
MDR report key: 19816116
·
Received July 24, 2024
Report
- Report Number
- 3003832357-2024-00559
- Event Type
- Injury
- Date Received
- July 24, 2024
- Date of Event
- June 24, 2024
- Report Date
- November 5, 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
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
DESCRIBE EVENT OR PROBLEM UPDATED. TYPE OF REPORTED COMPLAINT UPDATED TO SERIOUS INJURY. PATIENT CODE GRIDS UPDATED.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT DEVICE FAILED TO PACE. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT DEVICE FAILED TO PACE. THERE WAS NO INJURY CAUSED BUT THERE WAS A DELAY IN LIFE SAVING THERAPY AND AS SUCH THIS IS BEING CLASSIFIED AS A POTENTIAL SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 355863 | TEMPUS LS-MANUAL | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3020 | 07613365002737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening |