FDA Adverse Event
Summary report: N
4085 SURGICAL TABLE
MDR report key: 3180465
·
Received June 20, 2013
Report
- Report Number
- 1043572-2013-00063
- Date Received
- June 20, 2013
- Date of Event
- May 10, 2013
- Report Date
- June 20, 2013
- Manufacturer
- STERIS CORPORATION - MONTGOMERY
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE TECHNICIAN INSPECTED THE TABLE AND WAS ABLE TO DUPLICATE THE REPORTED EVENT. THE TECHNICIAN REPLACED THE FLOOR LOCK MANIFOLD, TESTED THE TABLE, AND RETURNED IT TO SERVICE.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THE SURGICAL TABLE BECAME UNLOCKED DURING A PATIENT PROCEDURE. NO INJURIES TO HOSPITAL STAFF OR PATIENTS WERE REPORTED. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279941 | 4085 SURGICAL TABLE | SURGICAL TABLE | FQO | STERIS CORPORATION - MONTGOMERY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |