MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-28 for KFA, GEHC, SIGNA 1.5T 4CH PA 9896-031-01591 manufactured by Carma Salud, S.l..
[140437831]
The investigation is still ongoing for this event. When the investigation is complete a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[140437832]
Knee coil came into service as a normal routine repair with no indications of heating or patient involvement. During the repair process, invivo technician discovered the housing of the coil was warped (from heating) in an area that would be in constant contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056069-2019-00001 |
| MDR Report Key | 8461396 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-25 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2016-10-25 |
| Date Added to Maude | 2019-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MR. KENNETH REVENNAUGH |
| Manufacturer Street | C/ DISC |
| Manufacturer City | MADRID 28022 |
| Manufacturer Country | SP |
| Manufacturer Postal | 28022 |
| 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 | 0 |
| Brand Name | KFA, GEHC, SIGNA 1.5T 4CH PA |
| Generic Name | KFA, GEHC, SIGNA 1.5T 4CH PA |
| Product Code | MOS |
| Date Received | 2019-03-28 |
| Returned To Mfg | 2019-03-04 |
| Model Number | 9896-031-01591 |
| Catalog Number | 9896-031-01591 |
| Lot Number | N/A |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARMA SALUD, S.L. |
| Manufacturer Address | C/ DISC?BOLO, 91-P4-2?A MADRID 28022 SP 28022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-28 |