MAUDE Adverse Event Report: RESPIRONICS, INC WHISPER SWIVEL; WHISPER SWIVELL

Model Number	332113
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a whisper swivel disconnected from the ventilator circuit during use.There was no harm or injury reported.The whisper swivel has not yet been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported a whisper swivel disconnected from the ventilator circuit during use.The actual whisper swivel used was not returned.Brand new whisper swivels were returned for evaluation.The hme (heat and moisture exchanger) used by the customer was not available to be tested with the whisper swivel.The whisper swivel was tested with a covidian dar hme.The manufacturer could not confirm the complaint and could not determine a root cause for the complaint.

• Brand Name: WHISPER SWIVEL
• Common Device Name: WHISPER SWIVELL
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13598018
• Report Number: 2518422-2022-07233
• Device Sequence Number: 12224370
• Product Code: BZD
• UDI-Device Identifier: 00606959015166
• UDI-Public: 00606959015166
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K962203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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: 332113
• Device Catalogue Number: 332113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown