FDA Adverse Event
Malfunction
Summary report: N
PORTABLE AC/DC SUCTION MACHINE
MDR report key: 20301623
·
Received September 25, 2024
Report
- Report Number
- 3006446479-2024-00004
- Event Type
- Malfunction
- Date Received
- September 25, 2024
- Date of Event
- September 23, 2024
- Report Date
- September 25, 2024
- Manufacturer
- VEGA TECHNOLOGIES / DICKSON ASIA GROUP, LTD.
- Product Code
- LRQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE CUSOTMER REPORTED THE UNIT DID NOT FUNCTION PROPERLY, CAUSING ONE OF THEIR PATIENTS TO SEEK MEDICAL INTERVENTION. THE CUSTOMER NOTED THE PATIENT IS A VENT PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1198870 | PORTABLE AC/DC SUCTION MACHINE | SUCTION MACHINE | LRQ | VEGA TECHNOLOGIES / DICKSON ASIA GROUP, LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |