MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-19 for MED-VAC VACUUM IMMOBILIZATION BAG VMR 433X01 27035 manufactured by Cfi Medical Solutions.
[5382624]
No manufacturer instructions or recommendations for storage. When not in use at our facility, the immobilizer was fastened around the hand pump that accompanies the product and stored on a shelf in an upright position. When needed for infant mri on (b)(6) 2015, the immobilizer was removed from storage, secured with straps around the infant and the med-vac hand pump was used to evacuate air from the immobilizer. When all air was removed using the pump, the area of the immobilizer surrounding the infant's head/neck was not as rigid as the lower portion. After removal from infant it was noted that fewer beads were distributed in the area near the upper section that surrounds the infant's head/neck area. Immobilizer was then shaken to redistribute beads evenly throughout and tested with findings of greater rigidity in head/neck area. Immobilizer will no longer be stored in upright position and will be checked prior to each use to insure that beads are evenly distributed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040362 |
| MDR Report Key | 4450872 |
| Date Received | 2015-01-19 |
| Date of Report | 2015-01-19 |
| Date of Event | 2015-01-08 |
| Date Added to Maude | 2015-01-27 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MED-VAC VACUUM IMMOBILIZATION BAG |
| Generic Name | IMMOBILIZER |
| Product Code | FZF |
| Date Received | 2015-01-19 |
| Model Number | VMR 433X01 27035 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CFI MEDICAL SOLUTIONS |
| Manufacturer Address | 14241 FENTON RD. FENTON MI 48430 US 48430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-19 |