FDA Adverse Event
Summary report: N
3085 SP SURGICAL TABLE
MDR report key: 5098785
·
Received September 23, 2015
Report
- Report Number
- 1043572-2015-00091
- Date Received
- September 23, 2015
- Date of Event
- September 1, 2015
- Report Date
- September 23, 2015
- Manufacturer
- STERIS CORPORATION - MONTGOMERY
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
STERIS MONITORS RELEVANT WEBSITES AND SOCIAL MEDIA SOURCES PER OUR SOCIAL MEDIA POLICY TO IDENTIFY POTENTIAL COMPLAINTS. THROUGH THIS PROCESS, STERIS IDENTIFIED AN ANONYMOUS POST REPORTING THAT THEIR 3085 SP SURGICAL TABLE WAS NOT OPERATING PROPERLY. STERIS RESPONDED AND PROVIDED CONTACT INFORMATION INCLUDING A PHONE NUMBER HOWEVER; STERIS HAS NOT RECEIVED A RESPONSE. BASED ON THE INFORMATION PROVIDED IN THE ANONYMOUS POST THIS EVENT APPEARS TO MEET OUR REPORTING CRITERIA FOR MEDICAL DEVICES. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED THAT THEIR 3085 SP SURGICAL TABLE WAS NOT OPERATING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 629914 | 3085 SP SURGICAL TABLE | SURGICAL TABLE | FQO | STERIS CORPORATION - MONTGOMERY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |