inforMED
MalfunctionINM

UMF MEDICAL

Received Dec 11, 2014

Report 2518399-2014-00001 · MDR key 4445196

Device

Generic name

Manual Phlebotomy/ent Chair

Model number

8612

Product problems

  • Device Operates Differently Than Expected

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

TABLE WAS MANUFACTURED AND SOLD TO CUSTOMER IN 2006. DOCTOR WAS ASKED ABOUT THE PATIENT WEIGHT TO MAKE SURE THE PATIENT WEIGHT DID NOT EXCEED THE 275 LB WEIGHT CAPACITY AND HE DID NOT ELABORATE ON PATIENT WEIGHT. CUSTOMER CONFIRMED PRODUCT WAS IMMEDIATELY TAKEN OUT OF SERVICE. CUSTOMER COULD NOT IDENTIFY ANY STRUCTURAL FAILURES THAT WERE NOTICEABLE. WAITING TO RECEIVE THE PRODUCT BACK FROM THE CUSTOMER. (B)(4) MEDICAL WILL INVESTIGATE TO DETERMINE IF MISUSE APPLIED OR IF A STRUCTURAL FAILURE TOOK PLACE.

Description of Event or Problem

CHAIR FELL OVER WHEN PATIENT WAS FULLY RECLINED IN THE CHAIR.

Remedial action

  • Other