FDA Adverse Event
Injury
Summary report: N
TEMPUS LS MANUAL
MDR report key: 17248961
·
Received July 3, 2023
Report
- Report Number
- 3003832357-2023-00426
- Event Type
- Injury
- Date Received
- July 3, 2023
- Date of Event
- June 6, 2023
- Manufacturer
- SCHILLER AG
- Product Code
- LDD
- PMA / PMN Number
- K200849
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 0
THIS COMPLAINT HAS BEEN DEEMED A DUPLICATE OF (B)(4). DEVICE INVESTIGATION WILL TAKE PLACE ON (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THERE WERE DEVICE PACING FAILURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20954 | TEMPUS LS MANUAL | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening |