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

Model Number SE3690

Device Problems False Alarm (1013); No Audible Prompt/Feedback (2282); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): BUFFALO FILTER; 5900 genesee st; lancaster NY 14086
• Manufacturer (Section G): BUFFALO FILTER; 5900 genesee st; lancaster NY 14086
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 7335781
• MDR Text Key: 102580765
• Report Number: 1717344-2018-00348
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10884524001555
• UDI-Public: 10884524001555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1