6020F CHAIR
Received Oct 3, 2012 · Event occurred Sep 10, 2012
Report 3001452523-2012-00001 · MDR key 2774294
Device
Generic name
Blood Drawing Chair
Manufacturer
Clinton IndustriesModel number
6020FCatalog number
6020F
Lot number
NA
Product problems
- Component Falling
Patient
NI
- Syncope
- Fall
- Head Injury
Narrative
Description of Event or Problem
AS DESCRIBED TO CLINTON INDUSTRIES BY EMAIL FROM (B)(6), END-USER FACILITY, (B)(6): AFTER COMPLETING A BLOOD DRAW FOR RESEARCH PURPOSES AND STILL SEATED IN THE CHAIR WITH THE ARM REST ACROSS HIS BODY, THE RESEARCH PARTICIPANT FAINTED AND FELL FORWARD. AS HE WAS FALLING TO THE FLOOR THE CHAIR WAS TIPPING WITH HIM. THE INDIVIDUAL SUSTAINED SIGNIFICANT FACIAL INJURIES RELATED TO THE FALL. AS DESCRIBED TO CLINTON INDUSTRIES BY EMAIL FROM (B)(6), (DISTRIBUTOR OF DEVICE INVOLVED) DURING A TAPED TELEPHONE INTERVIEW OF "(B)(6)" (LAST NAME INAUDIBLE) FROM (B)(6): PATIENT PASSED-OUT AFTER THE PUNCTURE IN THE ARM, ARM OF THE CHAIR WAS DOWN, THEY HUNCHED DOWN AND THE WHOLE CHAIR FLIPPED FORWARD. THEY FELL ONTO THE GROUND CAUSING SIGNIFICANT INJURIES.
Additional Manufacturer Narrative
PICTURES OF THE CHAIR IN QUESTION WHERE INCLUDED FROM THE END USER AND DID NOT SHOW ANY DEFECTS OR FAILURES.
Remedial action
- Other