OHIO MEDICAL
Received Jun 17, 2013
Report 1419185-2013-00002 · MDR key 3182070
Device
Generic name
Suction Regulator
Manufacturer
Ohio Medical CorpModel number
PTS ISUCatalog number
8701-1251-901
Lot number
NA
Product problems
- Insufficient Device Problem Information
Patient
NA
- Injury
Narrative
Description of Event or Problem
(B)(6) HOSPITAL, (B)(6), CALLED OHIO MEDICAL CORP; (B)(6) IS THE BIOMEDICAL TECHNICIAN THAT REPORTED THE INCIDENT. (B)(6) REPORTED THAT ONE OF OUR PUSH-TO-SET VACUUM REGULATOR WAS RECENTLY INVOLVED IN A PT INJURY; HOWEVER HE DID NOT HAVE ANY OTHER SPECIFIC INFORMATION REGARDING THE SERIAL NUMBER OR THE INVOLVEMENT OF THE UNIT FOR THIS PARTICULAR INCIDENT AT THE TIME AS HE HAS NOT BEEN INFORMED OF ANY ADDITIONAL INFORMATION IN REGARD TO THIS UNIT.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN SENT TO OHIO MEDICAL CORP. OHIO MEDICAL CORP ENGINEERING AND QUALITY PERSONNEL HAVE SPOKEN TO (B)(6). SINCE (B)(6) WAS INFORMED OF THE INCIDENT BY A DIFFERENT PERSON, HE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.