MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-18 for NEONATE IMAGING SUB-SYSTEM NISS-MR N/A manufactured by Sree Medical Systems.
[17725297]
The (b) (6) acute transport nurses transported an infant nicu patient to the pediatric mri suite in the mri safe incubator. When the mri technologists were preparing the baby for the scan they discovered that one of the smaller side wall access doors was broken at the hinge. The swat nurse informed the technologists that the door broke off the hinge as they were preparing the infant for travel. The technologists did not feel that the door posed a safety threat to the child and proceeded with a successful exam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1804431 |
| MDR Report Key | 1804431 |
| Date Received | 2010-07-18 |
| Date of Report | 2010-07-16 |
| Date of Event | 2010-06-28 |
| Report Date | 2010-07-16 |
| Date Reported to FDA | 2010-07-18 |
| Date Added to Maude | 2010-08-17 |
| 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 |
| 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 | NEONATE IMAGING SUB-SYSTEM |
| Generic Name | INCUBATOR, TRANSPORTER |
| Product Code | FPL |
| Date Received | 2010-07-18 |
| Model Number | NISS-MR |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SREE MEDICAL SYSTEMS |
| Manufacturer Address | 4700 LAKESIDE AVE. SUITE 400 CLEVELAND OH 44114 US 44114 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-18 |