FDA Adverse Event
Malfunction
Summary report: N
DECOMPRESSION OF CHOICE
MDR report key: 23291041
·
Received October 15, 2025
Report
- Report Number
- 3007278668-2025-00002
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- September 30, 2025
- Report Date
- November 18, 2025
- Manufacturer
- PIVOTAL HEALTH SOLUTIONS, INC
- Product Code
- ITH
- UDI-DI
- 00852753008907
- PMA / PMN Number
- K101889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IS BEING RETURNED TO MANUFACTURER FOR EVALUATION. EVALUATION OF INITIAL INFORMATION APPEARS IT WAS LIKELY THERE WAS A WELD FAILURE.
Additional Manufacturer Narrative · 0
THE DEVICE AND PART E7130 WERE EVALUATED AND A DEFECT IN THE WELD WAS IDENTIFIED AS THE ROOT CAUSE FOR THE MALFUNCTION THAT OCCURRED IN THIS REPORTED INCIDENT.
Description of Event or Problem · 0
A WELD ON PART E7130 APPEARS TO HAVE FAILED AND THE PIECE OF THE TABLE CONNECTED THROUGH THE E7130 WELD FELL TO THE GROUND.
Description of Event or Problem · 0
A WELD ON PART E7130 APPEARS TO HAVE FAILED AND THE PIECE OF THE TABLE CONNECTED THROUGH THE E7130 WELD FELL TO THE GROUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1993288 | DECOMPRESSION OF CHOICE | DOC | ITH | PIVOTAL HEALTH SOLUTIONS, INC | E9011 | 00852753008907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |