MAUDE Adverse Event Report: BUFFALO FILTER RAPIDVAC; APPARATUS, EXHAUST, SURGICAL

Model Number	SE3690
Medical Device Problem Codes	False Alarm (1013); No Audible Prompt/Feedback (2282); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit would not make a noise when pencil was activated.The patient incurred a minor burn on inner thighs.There was no medical intervention needed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one device was received as a service request and a visual inspection and functional test were performed by the supplier.A device history review was completed for serial# (b)(4) of which was produced on june 2, 2016.There were no manufacturing issues related to the complaint for this serial number.Inspection of the device resulted in noting that the returned unit required replacement of the insulation components.The device failed the performance test.This complaint will be considered as confirmed.The exact root cause of the failure could not be determined; however these items are subject to wear and tear with use.As part of continuous improvement efforts and a corrective action, the supplier repaired and returned the unit.If additional information is received, the investigation will resume as needed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RAPIDVAC
• Common Device Name: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): BUFFALO FILTER; 5900 genesee st; lancaster NY 14086
• MDR Report Key: 7335781
• Report Number: 1717344-2018-00348
• Device Sequence Number: 61799
• Product Code: FYD
• UDI-Device Identifier: 10884524001555
• UDI-Public: 10884524001555
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: SE3690
• Device Catalogue Number: SE3690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 08/08/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 07/25/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1