MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-29 for NOT DETERMINED manufactured by Invivo Corporation.
[55989690]
Event is under investigation and update will be provided on a later date.
Patient Sequence No: 1, Text Type: N, H10
[55989691]
A sedated infant was scanned with the nvc 1. 5t coil head first in a supine position for a brain scan when the patient received a 2nd degree burn on their foot approximately 3cm blister.
Patient Sequence No: 1, Text Type: D, B5
[62827784]
Based on the provided information and test performed on site, there is no indication of a malfunction of the coil used. No definite cause for the injury on the patient left leg could be determined. The coil was checked after the examination. The coil passed the performed tests. No damage was observed and the coil did not become too hot to touch. The spo2 sensor was close to the affected area but is not likely to have caused the injury. The sensor is mr safe and the monitoring device with the same accessories was used before and after the incident in a similar set up without problems. The patient was covered by a blanket of 100% polyester. The blanket may have contributed to the incident; however, the development of the blister was not observed as the area was covered with the blanket. Also, the blanket is made of polyester; polyester is an insulator and therefore hinders the heat dissipation. The blanket does not contain conductive materials. Neither the elephant application, nor the seams (yarn) are suspected to be conductive (judged by photographic evaluation). The nurse treated the affected skin area. The skin is expected to heal completely. The customer was informed to always follow the instructions for use of each accessory used during an examination. It is required even with mr conditional /safe equipment to prevent direct contact between cabling and the patient's body. Based on the provided information and test performed on site, there is no indication of a malfunction of the coil used.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2016-00003 |
| MDR Report Key | 5988590 |
| Date Received | 2016-09-29 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-08-29 |
| Date Mfgr Received | 2016-08-30 |
| Device Manufacturer Date | 2014-01-22 |
| Date Added to Maude | 2016-09-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KENNETH REVENNAUGH |
| Manufacturer Street | 3545 SW 47TH AVE |
| Manufacturer City | GAINSVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer G1 | PHILIPS HEALTHCARE - INVIVO DIAGNOSTIC IMAGING |
| Manufacturer Street | 3545 SW 47TH AVE |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NOT DETERMINED |
| Product Code | MOS |
| Date Received | 2016-09-29 |
| Lot Number | N/A |
| 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 SW 47TH AVE GAINSVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-29 |