FDA Adverse Event
Malfunction
Summary report: N
OXYGEN REGULATOR
MDR report key: 20429404
·
Received October 10, 2024
Report
- Report Number
- MW5160969
- Event Type
- Malfunction
- Date Received
- October 10, 2024
- Report Date
- October 11, 2024
- Manufacturer
- CRAMER DECKER INDUSTRIES/ PRO RACK
- Product Code
- CAN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THE COMPLAINANT ALLEGES PRO MEDICAL EQUIPMENT SOLD AND INSTALLED A CRAMER DECKER MEDICAL OXYGEN REGULATOR - REGULATOR, PRESSURE, GAS CYLINDER - TO AN OXYGEN TANK AND THE COMPLAINANT ALLEGES THE DEVICE DID NOT WORK AND RESULTED IN THE OXYGEN TANK EMPTYING AFTER HALF AN HOUR. COMPLAINANT ALSO ALLEGES THE FIRM DID NOT UPHOLD THE WARRANTY FOR THE DEVICE. IT IS ALSO NOTED THAT THE COMPLAINANT¿S MOTHER WHO USED THE DEVICE IS OXYGEN DEPENDENT AND WITHOUT OXYGEN THE PATIENT¿S OXYGEN SATURATION GOES DOWN TO 78%.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346918 | OXYGEN REGULATOR | REGULATOR, PRESSURE, GAS CYLINDER | CAN | CRAMER DECKER INDUSTRIES/ PRO RACK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |