MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-09-04 for INVIVO/PHILIPS 9896-030-11603 manufactured by Invivo/philips.
[24991466]
(b)(4). 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
[24991467]
Invivo/philips received a report from a customer that a blister formed on the upper left thigh of a patient after an mr examination. The patient was positioned feet first for an examination of the right knee using the 8ch knee coil. Injury was classified as 2nd degree burn greater than 2. 5cm.
Patient Sequence No: 1, Text Type: D, B5
[41320967]
(b)(4). Based on the provided information and test performed on site and at the repair facility, it is concluded that the reddening of skin and blisters on the left leg were caused by contact between the coil cable and the patients leg. The padding that was placed between leg and cable shifted during the examination. As contributing factors were identified: a broken tuning capacitor of the coil used, that may have led to high cable currents in certain situations - the use of consecutive high sar scans (> 2wkg) - the routing of the cable (not parallel to the bore, but across). The instructions for use contains extensive warnings related to patient and coil/ cable positioning. It is clearly mentioned that 2 cm distance must be kept between coil cable and patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2015-00006 |
| MDR Report Key | 5055767 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-17 |
| Date of Event | 2015-08-07 |
| Date Mfgr Received | 2015-08-12 |
| Device Manufacturer Date | 2010-08-09 |
| Date Added to Maude | 2015-09-04 |
| 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 AVENUE |
| 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 | INVIVO/PHILIPS |
| Generic Name | SENSE KNEE COIL 1.5T 8CH |
| Product Code | MOS |
| Date Received | 2015-09-04 |
| Model Number | 9896-030-11603 |
| Catalog Number | 9896-030-11603 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO/PHILIPS |
| Manufacturer Address | 3545 SW 47TH AVENUE GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-04 |