MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-05-01 for SENSE NV16 1.5T 4535-300-61252 manufactured by Invivo Corporation.
[3421641]
During a scanning process, the pt was positioned supine head first in a philips intera 1. 5t achieva nova dual system. A sense (b)(4) 1. 5t coil in combination with a sense spine coil 1. 5t 15ch were used to perform a scanning process. After the examination, a second degree burn of 1. 5 centimeters was observed on the right elbow of the pt. Based on customer complaint description burn location matches with a possible contact between the skin and the bazooka filter of the sense (b)(4) coil system cable.
Patient Sequence No: 1, Text Type: D, B5
[10702792]
(b)(4). The investigation is still ongoing on this event. When the investigation is completed a follow up report will be sent to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2013-00002 |
| MDR Report Key | 3096928 |
| Report Source | 08 |
| Date Received | 2013-05-01 |
| Date of Report | 2013-04-05 |
| Date of Event | 2013-02-15 |
| Date Mfgr Received | 2013-04-05 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-05-08 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KENNETH REVENNAUGH, DIR, Q&R |
| Manufacturer Street | 3545 S.W. 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523360010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSE NV16 1.5T |
| Generic Name | NONE |
| Product Code | MOS |
| Date Received | 2013-05-01 |
| Model Number | 4535-300-61252 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORPORATION |
| Manufacturer Address | 3545 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-01 |