MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-18 for ACE MEDICAL COMPANY 1303 1304 1305 SAA manufactured by Ace Medical Company.
[15361]
On 4/21/94 and agin on 6/17/94 we noted that patients wearing halo (open back) experienced warm sensation or a type of electrical shock when imaging begins in the mri unit - company representative states that this halo works with a 1. 0 or less tesla mri. Our unit is a 1. 5 tesla and they further stated that this type of unit does experience problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25392 |
| MDR Report Key | 25392 |
| Date Received | 1995-01-18 |
| Date Added to Maude | 1995-09-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACE MEDICAL COMPANY |
| Generic Name | OPEN BACK HALO RING |
| Product Code | CBS |
| Date Received | 1995-01-18 |
| Model Number | 1303 1304 1305 |
| Catalog Number | SAA |
| Lot Number | N.A. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25891 |
| Manufacturer | ACE MEDICAL COMPANY |
| Manufacturer Address | 14105 S. AVALON BLVD. L.A CA 90061 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-01-18 |