MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08,distributor report with the FDA on 2015-02-03 for DS ANTERIOR 3.0T 9896-030-24082 manufactured by Invivo Corp.
[5344101]
A sedated male patient was positioned feet first supine and scanned with anterior coil for an abdomen examination. After the examination, necrosis of the skin on the upper right arm was observed. With-in a patient heating questionnaire it was mentioned that the cable of the mentioned coil was touching near the affected area.
Patient Sequence No: 1, Text Type: D, B5
[12911162]
(b)(4). Method, results, conclusions: the investigation is still ongoing on this event. When the investigation is completed a f/u report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[24711620]
Pr#: 3(b)(4). Based on the provided information and tests performed on site there is no indication of a malfunction of the mr system or coil. The injury as sustained by the patient is caused by a combination of factors. The main cause is considered to be the close proximity of the right upper arm to the magnet bore in combination with the direct contact with the coil cable to the affected area led to the injury as sustained by the patient. Padding was not used between the coil cable and patients skin or between the magnet bore and the right upper arm. Other factors that contributed to the injury are: the patient had a hampered thermo-regulation and was unable to alert the operator because he was sedated. 5 scans on high sar value were conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2015-00005 |
| MDR Report Key | 4487163 |
| Report Source | 08,DISTRIBUTOR |
| Date Received | 2015-02-03 |
| Date of Report | 2015-01-30 |
| Date of Event | 2015-01-06 |
| Date Mfgr Received | 2015-01-26 |
| Device Manufacturer Date | 2013-07-19 |
| Date Added to Maude | 2015-02-06 |
| 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 | DS ANTERIOR 3.0T |
| Generic Name | AC2 |
| Product Code | MOS |
| Date Received | 2015-02-03 |
| Model Number | 9896-030-24082 |
| 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 | 2015-02-03 |