FDA Adverse Event
Injury
Summary report: N
TEMPUS LS-MANUAL
MDR report key: 19816114
·
Received July 24, 2024
Report
- Report Number
- 3003832357-2024-00560
- Event Type
- Injury
- Date Received
- July 24, 2024
- Date of Event
- July 9, 2024
- Report Date
- October 21, 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
PATIENT INFORMATION UPDATED. PATIENT OUTCOME AND HEALTH IMPACT GRIDS UPDATED.
Additional Manufacturer Narrative · 0
TYPE OF REPORTED COMPLAINT UPDATED.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT DEVICE EXPERIENCED DPM FAILURE. 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 EXPERIENCED DPM FAILURE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 355861 | TEMPUS LS-MANUAL | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3020 | 07613365002737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| L |