MAUDE Adverse Event Report: MEDTEC, INC., DBA CIVCO MEDICAL SOLUTIONS AND CIVC TYPE-S EXTENSION, VARIAN STYLE

Model Number	MTCFHNV
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Risk: while repositioning a patient when a head, neck, and shoulder thermoplastic mask is docked, and an upward force is applied, and patient moved superiorly there is potential the extension is no longer securely attached.If the extension disengages and the patient is not caught, the patient may fall from a height that may require medical intervention.Mitigations: the event will only occur when a head, neck, and shoulder mask is docked and two therapists are lifting vertically and superiorly to move the patient.A patient would not be able to shift the extension vertically on their own and therefore it could not detach while the patient is alone or by arching their back.Therefore the probability of the patient falling in this situation is low as two therapists would be moving the patient on the sheet at the event of this happening and would then be supporting the patient when the extension disengages which would prevent a fall.Additionally, it is abnormal to lift the patient vertically when moving them.Typically, they may shift the patient maintaining contact with the table which would not cause the extension to detach.Conclusion: there is no design or quality error.This event would only occur during a specific patient positioning workflow of two therapists moving a patient on a sheet with the head, neck, and shoulder thermoplastic mask docked to the extension and lift the patient vertically and superiorly from both sides at the same time.It is abnormal to lift the patient vertically when repositioning, they may shift the patient maintaining contact with the table which would not cause the extension to detach.Civco will be updating the instruction manual to include a warning to not life the patient vertically while repositioning with a thermoplastic mask on and notifying customers of the specific workflow that could result in detachment of the extension.Report is late due to lapsed medwatch license.Once the license has been renewed, the mdr will be submitted immediately.
Event or Problem Description
Extension disengaged from the table when two therapists lifted the patient on a sheet while the patient was under a thermoplastic mask.Patient was supported by therapists holding sheet and did not fall.After taking kv images, it was decided that the patient needed adjustment for proper alignment for treatment.Therapists used a sheet underneath the patient to move the patient slightly further up into the head, neck, and shoulder thermoplastic mask and while doing so, the extension detached from the couch.The patient started to fall with the extension but was caught by the therapists.There were no injuries; the patient was just alarmed and scared during the incident.

• Brand Name: TYPE-S EXTENSION, VARIAN STYLE
• Common Device Name: TYPE-S EXTENSION
• Manufacturer (Section D): MEDTEC, INC., DBA CIVCO MEDICAL SOLUTIONS AND CIVC; 1401 8th street se; orange city, ia
• MDR Report Key: 10189608
• Report Number: 1932738-0620-02020
• Device Sequence Number: 16804601
• Product Code: IYE
• UDI-Device Identifier: 00841439104156
• UDI-Public: 00841439104156
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MTCFHNV
• Device Catalogue Number: MTCFHNV
• Device Lot Number: M371990
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/20/2020
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/24/2020
• 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