FDA Adverse Event
Malfunction
Summary report: N
TEMPUS LS-MANUAL
MDR report key: 22703265
·
Received August 4, 2025
Report
- Report Number
- 3003832357-2025-000598
- Event Type
- Malfunction
- Date Received
- August 4, 2025
- Date of Event
- July 11, 2025
- Report Date
- December 11, 2025
- Manufacturer
- SCHILLER AG
- Product Code
- LDD
- UDI-DI
- 07613365001693
- PMA / PMN Number
- K200849
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
UPDATED THE REPORTING INSTITUTION NAME AND EVENT DATE.
Additional Manufacturer Narrative · 0
UPDATED THE DEVICE PROBLEM CODE.
Description of Event or Problem · 0
THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND SCHILLER AG (EQUIPMENT MANUFACTURER) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS-MANUAL DEFIBRILLATOR INDICATING THAT THE DEVICE PROVIDES VISUAL TEXT ALERT WHEN ECG LEADS ARE REMOVED, BUT NOT AUDIBLE ALERTS. THE DEVICE ALSO GIVES NO AUDIO WHILE CHARGING FOR A SHOCK. .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203236 | TEMPUS LS-MANUAL | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3020 | 07613365001693 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |