MAUDE Adverse Event Report: CARMA SALUD, S.L. DS HEADNECK COIL 3.0T

Model Number	9896-032-08031
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
While being scanned, mirror assembly was attached to the mri coil.A screw had previously fell out of the assembly and during the scan the mirror dislodged from the assembly and fell to hit the patient's eye.No medical intervention was necessary.
Additional Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
Additional Manufacturer Narrative
A patient was scanned while the sensavue mirror was attached to the nvc coil.The mirror for nvc used for "sensavue" has come off and the mirror hits the patient's eyes.The screws for securing the mirror were disengaged.For this reason, the mirror struck the patient's eyes.The patient's cornea is hurting.Patient did not receive special treatment from hospital.Ncr 37458 was created to quarantine all mirrors in stock.During inspection it was noted that the torque of the screw was set too high and caused the screw to stretch or the head would shear off.Scar 19-001 was created for further analysis by the vender precision innovations, inc.During their investigations it was noted that the assemblies required a secondary operation of unassembling after precision innovation shipped.The mirror was not being assembled correctly and in order to utilize the mirror correctly site would have to disassemble these to correct the mirror then reassemble for use.Ecr-066751 was created to to indicate on the drawing the correct orientation of the mirror.Ecr-068964 was created to utile a more appropriate torque plus to include the use of a threadlocker to ensure the screws do not back out when in use in the field.All material in house is to be reworked using the latest approved drawing.Moving forward the mirrors have been corrected on the next revision drawing to provide correct positioning of mirror.Additionally vender to develop permanent instruction of screw install into final inspection.The cause of the customer complaint as described above is most likely attributed to a design error.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text : accessory was replaced by field service engineer.

• Brand Name: DS HEADNECK COIL 3.0T
• Common Device Name: DS HEADNECK COIL 3.0T
• Manufacturer (Section D): CARMA SALUD, S.L.; c/ discóbolo, 91-p4-2ºa; madrid 28022 ; SP 28022
• MDR Report Key: 8147940
• Report Number: 1056069-2018-00006
• Device Sequence Number: 10836840
• Product Code: MOS
• UDI-Device Identifier: 00884838067394
• UDI-Public: (01)00884838067394
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123492
• 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): 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9896-032-08031
• Device Catalogue Number: 9896-032-08031
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018; 11/26/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 05/01/2019; 05/01/2019
• 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
• Patient Age: 69 YR
• Patient Weight: 50