MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08,distributor report with the FDA on 2015-01-20 for FRU, HEADNECKSPINE COIL 1.5T 4535-303-60751 manufactured by Invivo Corp.
[5423322]
A male pt was positioned head first supine and scanned with the ds nvc coil for a cervical spine examination. The pt experienced a heating sensation and after the examination reddening of the skin and 2 blisters of 3/4 inch were observed in the pts left arm pit.
Patient Sequence No: 1, Text Type: D, B5
[12779980]
(b)(4). Method: the investigation is still ongoing on this event. When the investigation is completed a follow up report will be sent to the fda. Results: the investigation is still ongoing on this event. When the investigation is completed a follow up report will be sent to the fda. Conclusion: the investigation is still ongoing on this event. When the investigation is completed a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[31808219]
(b)(4). Based on the provided information and test performed on site there is no indication of a malfunction of the mr system or coil. It is concluded that this heating incident is a skin to skin heating incident caused by a rf current loop formation inside the left arm pit of the patient. No padding was used between the arms and side of the patient to prevent skin-skin contact. In this case several factors were observed that contributed to the sustained injury: the patient was obese and covered by a cotton sheet, 4 scans on high sar value were conducted and the total delivered specific energy dose (sed) was 3726 j/kg.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2015-00003 |
| MDR Report Key | 4448177 |
| Report Source | 08,DISTRIBUTOR |
| Date Received | 2015-01-20 |
| Date of Report | 2015-01-20 |
| Date of Event | 2014-12-30 |
| Date Mfgr Received | 2015-01-12 |
| Device Manufacturer Date | 2014-04-17 |
| Date Added to Maude | 2015-01-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KENNETH REVENNAUGH, DIR |
| Manufacturer Street | 3545 S.W. 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523360010 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRU, HEADNECKSPINE COIL 1.5T |
| Generic Name | NVC3 |
| Product Code | MOS |
| Date Received | 2015-01-20 |
| Model Number | 4535-303-60751 |
| 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 CORP |
| Manufacturer Address | 3545 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-20 |