MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-30 for AIRBORNE LIFE SUPPORT SERVICES 220H * manufactured by International Biomedical, Inc..
[92343]
A 33 week premature infant arrested during neonatal transport. Arrest mgmt/resuscitation impeded by device design. Iv lines run through gromnets so couldn't easily remove top of transporter for access to infant. Required third provider to hold top up so rn's could get to baby. This did not impact the outcome, however, made care very difficult.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011790 |
| MDR Report Key | 109481 |
| Date Received | 1997-07-30 |
| Date of Report | 1997-07-17 |
| Date of Event | 1997-05-08 |
| Date Added to Maude | 1997-08-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRBORNE LIFE SUPPORT SERVICES |
| Generic Name | NEONATAL TRANSPORTER |
| Product Code | FPL |
| Date Received | 1997-07-30 |
| Model Number | 220H |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 107610 |
| Manufacturer | INTERNATIONAL BIOMEDICAL, INC. |
| Manufacturer Address | 8508 CROSS PARK DR. AUSTIN TX 787544557 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-30 |