FDA Adverse Event
Malfunction
Summary report: N
OXYTOTE
MDR report key: 19228554
·
Received May 2, 2024
Report
- Report Number
- 19228554
- Event Type
- Malfunction
- Date Received
- May 2, 2024
- Date of Event
- April 27, 2024
- Report Date
- April 30, 2024
- Manufacturer
- WESTERN/SCOTT FETZER COMPANY
- Product Code
- CAN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
EVENTS ON SAME DAY. EVENT #1: O2 TANK DISPLAYING ERROR MESSAGE. ERROR MESSAGE ON TANK THAT APPEARED FULL. GAUGE ON TANK IS DEFECTIVE. REMOVE TANK FROM SERVICE. EVENT #2: O2 TANK DISPLAYING ERROR MESSAGE (2ND TANK TODAY, SAME UNIT CCU). ERROR MESSAGE ON TANK THAT APPEARED FULL. GAUGE ON TANK IS DEFECTIVE. REMOVED TANK FROM SERVICE. MANUFACTURER RESPONSE FOR DIGITAL OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER) RETURNED TO MANUFACTURER VIA OUR DISTRIBUTOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 811647 | OXYTOTE | REGULATOR, PRESSURE, GAS CYLINDER | CAN | WESTERN/SCOTT FETZER COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |