MAUDE Adverse Event Report: CARMA SALUD, S.L. KFA, GEHC, SIGNA 1.5T 4CH PA

Model Number	9896-031-01591
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still ongoing for this event.When the investigation is complete a follow-up report will be sent to the fda.
Event or Problem Description
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.
Additional Manufacturer Narrative
A coil was returned to invivo service & repair for normal repair under rma (b)(4).Coil was returned for low signal.There was no indication from the customer/end user that would indicate a patient was involved, nor any heating incidents.Upon inspection of coil during repair it was noticed that there was an overcurrent condition.The coil was scrapped determined to be beyond economical repair.The site will receive a supply stock in it's replacement.Repair tech indicates that the current state of the coil failed the bench test on all transmit channels.This failure would flag the system to abort scanning if the site was using under clinical use.The coil was delivered to have an engineering evaluation review.After investigation and determination it was noted that from the location and the type of overcurrent conditions, was from transmitting into the coil from the body coil with in the magnet.This information is provided with all coil in the user manual.The cause of the customer complaint as described above is most likely attributed to a use error.

• Brand Name: KFA, GEHC, SIGNA 1.5T 4CH PA
• Common Device Name: KFA, GEHC, SIGNA 1.5T 4CH PA
• Manufacturer (Section D): CARMA SALUD, S.L.; c/ discóbolo, 91-p4-2ºa; madrid 28022 ; SP 28022
• MDR Report Key: 8461396
• Report Number: 1056069-2019-00001
• Device Sequence Number: 16590265
• Product Code: MOS
• UDI-Device Identifier: 00884838081529
• UDI-Public: (01)00884838081529
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 9896-031-01591
• Device Catalogue Number: 9896-031-01591
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019; 03/07/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/05/2019; 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other