OHMEDA PEDIATRIC AEROSOL TENT
Received Aug 13, 1998 · Event occurred Feb 16, 1998
Report 1121732-1998-00007 · MDR key 182157
Device
Generic name
Pediatric Aerosol Tent
Manufacturer
Ohmeda MedicalModel number
UNKCatalog number
NA
Lot number
NA
Product problems
- Use of Device Problem
Patient
5 MO
- No Consequences Or Impact To Patient
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
WHEN AN OHMEDA TELEMARKETER WAS TALKING TO A HOSPITAL EMPLOYEE (IN JULY 1998) ABOUT PURCHASING NEW EQUIPMENT, IT WAS REPORTED THAT THERE HAD BEEN AN INCIDENT IN FEBRUARY 1998 ON AN OHMEDA PEDIATRIC AEROSOL TENT. NO DETAILS WERE AVAILABLE AT THAT TIME. THE RISK MRG OF THE HOSPITAL WAS THEN CONTACTED FOR ADDITIONAL INFORMATION, AND STATED THAT A 5 MONTH OLD, LARGE, ACTIVE INFANT WAS TREATED IN THE TENT WITH HIS/HER PARENTS IN THE ROOM, AND WAS FOUND WRAPPED IN THE PLASTIC CANOPY. NO INJURY WAS SUSTAINED. THE RISK MRG STATED THAT THE HOSPITAL HAD EVALUTED THE EQUIPMENT AND IT WAS FOUND TO BE COMPLETELY FUNCTIONAL WITH NO PROBLEMS. SHE ALSO SAID THAT THE HOSPITAL DETERMINED THAT THE INCIDENT WAS PROBABLY THE RESULT OF THE PARENTS UNTUCKING THE CANOPY FROM THE MATTRESS, ALTHOUGH IT WAS DESIGNED TO BE TUCKED UNDERNEATH THE MATTRESS. ADDITIONAL DETAILS WERE REQUESTED BUT NO RESPONSE HAS BEEN REC'D.