PTS ISU
Received Jun 17, 2016
Report 1419185-2016-00028 · MDR key 5732897
Device
Generic name
Vacuum Regulator
Manufacturer
Ohio Medical LlcModel number
1251Catalog number
8701-1251-905
Lot number
ISU147092
Product problems
- Device Slipped
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED.
Description of Event or Problem
USER FACILITY REPORT (B)(4) WAS RECEIVED BY MANUFACTURER ON (B)(6) 2016 STATING "THE VACUUM REGULATOR COMES LOOSE FROM WALL OUTLET. AT TIMES THE REGULATOR LEANS FORWARD COMPROMISING SUCTION." INITIAL REPORTER WAS CONTACTED ON (B)(6) 2016 AND STATED THAT THE DEVICE WAS NOT IN USE DURING OCCURENCE. SHE STATED THAT SHE WAS TOLD "THOSE REGULATORS ALWAYS HAVE THAT PROBLEM" BUT COULD NOT PROVIDE ANY FURTHER DETAIL ON WHAT DEGREE OF "COMPROMISING SUCTION" AS STATED IN USER REPORT HAD OCCURED AS SHE WAS NOT PRESENT. RETURN MATERIAL AUTHORIZATION WAS OPENED AND INITIAL REPORTER STATED THAT DEVICE WOULD BE RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER FURTHER INFORMATION AND TO HAVE DEVICE IN QUESTION RETURNED. ON (B)(6) 2016 (B)(6) STATED "AS FAR AS I CAN TELL, IT [DEVICE] SEEMS TO BE IN GOOD WORKING CONDITION."