MAUDE Adverse Event Report: RESPIRONICS, INC. DORMA 100; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	101V
Medical Device Problem Codes	Degraded (1153); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to seeing black particles/dots on the face.There was no report of patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
Upon further review, the device not contain sound abatement foam that would be likely to cause or contribute to death or serious injury and is not in scope of res 88058.Therefore, there is no allegation of a reportable event associated with the device at this time.
Additional Manufacturer Narrative
The manufacturer previously reported received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.Section h6 medical device problem code was coded incorrectly on the previous report.
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging to seeing black particles/dots on the face.There was no report of patient harm or injury.Upon further review, the device did not contain sound abatement foam that would be likely to cause or contribute to death or serious injury and is not in scope of 177391.Therefore, there is no allegation of a reportable event associated with the device at this time.

• Brand Name: DORMA 100
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13592711
• Report Number: 2518422-2022-07109
• Device Sequence Number: 4018918
• Product Code: BZD
• UDI-Device Identifier: 00606959038424
• UDI-Public: 00606959038424
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K130077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/06/2022

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: Lay User/Patient
• Device Model Number: 101V
• Device Catalogue Number: 101V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 04/03/2022; 10/27/2022; 10/27/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/05/2022; 11/01/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown