POSEY BED
Received Feb 16, 2012
Report 2020362-2012-00078 · MDR key 2478495
Device
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
NA
- No Patient involvement
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE TEETH WILL NOT ALIGN WHEN AN ATTEMPT IS MADE TO SECURE THE TEETH SHUT. THE ISSUE WAS DISCOVERED DURING SETUP. THERE WAS NO PATIENT CONTACT OR INJURY REPORTED.
Additional Manufacturer Narrative
(B)(4) ZIPPER DOES NOT ALIGN. RESULTS - INSPECTION OF THE RETURNED PRODUCT REVEALED THE PATIENT ACCESS PANEL SIDE A ZIPPER SLIDER BODY IS OPEN AND THE PULL TAB IS MISSING. ADDITIONALLY PANEL SIDE B HAS TWO PULL TABS THAT ARE MISSING. PANEL SIDE C LEG SLIDER IS CLOSED. WINDOW SIDE A HAS ONE INCH OF THE NETTING THAT WAS INSERTED OUT. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: NEVER TRY TO RIP A PANEL OPEN AS THIS MAY DAMAGE THE ACCESS PANEL OR THE ZIPPER SLIDER BY BENDING IT OPEN. NEVER USE THE BED IF A ZIPPER SLIDER IS BENT OPEN OR DAMAGED, AS THIS MAY PREVENT THE ZIPPER FROM CLOSING SECURELY. NEVER LEAVE THE PATIENT'S BEDSIDE UNTIL ALL ACCESS PANEL ZIPPERS ARE SECURELY CLOSED. TEST THE ENTIRE LENGTH OF EACH ZIPPER BY PRESSING AGAINST THE PANEL NEAR THE ZIPPER TO MAKE SURE IT IS SECURELY CLOSED AND THE ACCESS PANEL WILL NOT OPEN WHEN PRESSURE IS APPLIED. NEVER USE THE BED IF THE ZIPPER PULL-TAB IS MISSING OR BROKEN. (B)(4).