inforMED
MalfunctionCCX

DANNY SLING

Received Jun 7, 2021 · Event occurred May 23, 2021

Report 11945931 · MDR key 11945931

Device

Generic name

Support, Patient Position

Manufacturer

Bird & Cronin, Llc

Product problems

  • Component Missing
  • Defective Device

Patient

90 DA

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

(B)(6) ORDERED FOR REFLUX PRECAUTIONS. INFANT KEPT SLIDING OUT OF THE BOTTOM OF THE (B)(6) . GRABBED A NEW ONE FROM THE SUPPLY ROOM AND NOTICED THAT THERE SHOULD BE VELCRO AT THE END OF THE FLAP THAT FOLDS OVER BABY. THE VELCRO FROM THE STRAPS ATTACHES TO THE VELCRO ON THE FLAP TO SECURE THE INFANT. THE 1ST (B)(6) USED DID NOT HAVE THAT VELCRO, WHICH IS APPARENTLY WHY INFANT WAS SLIDING OUT THE BOTTOM. THE NEW SLING WAS ATTACHED TO THE BED, AND INFANT SECURED. MANAGER REVIEW: (B)(6) KEPT FOR REVIEW. THERE IS NO VELCRO STRIP ON THE BOTTOM FLAP THAT PULLS UP BETWEEN A BABY'S LEGS AND PREVENTS THEM FROM SLIPPING DOWN. THERE IS VELCRO ON THE STRAPS THAT CROSS OVER THE BABY'S BELLY. THIS IS A PRODUCT DEFECT.