MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-08-13 for OHMEDA PEDIATRIC AEROSOL TENT UNK NA manufactured by Ohmeda Medical.
[110211]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121732-1998-00007 |
| MDR Report Key | 182157 |
| Report Source | 05,06 |
| Date Received | 1998-08-13 |
| Date of Report | 1998-07-24 |
| Date of Event | 1998-02-16 |
| Date Mfgr Received | 1998-07-24 |
| Date Added to Maude | 1998-08-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OHMEDA PEDIATRIC AEROSOL TENT |
| Generic Name | PEDIATRIC AEROSOL TENT |
| Product Code | BYK |
| Date Received | 1998-08-13 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 177107 |
| Manufacturer | OHMEDA MEDICAL |
| Manufacturer Address | 9065 GUILFORD ROAD COLUMBIA MD 210461801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1998-08-13 |