MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1060657
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Event or Problem Description
The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.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
The manufacturer previously reported hospitalization - initial or prolonged in b.2 section, which was marked incorrectly as this is product problem only as mentioned in b.1 section in previous report.A.1 section was inorrect patient intial name was reported in the previous report, which correctly updated in this follow up report as unknown.G.2 section was missing the previous report, in this correction report it is correctly marked as consumer.E.1 section was missing in the previous report, which is correctly updated in this follow up report.D.9 and h.3 section incorrectly reported as no in the previous report, which is correctly reported as yes in this follow up report.H.10 comment was missing in previous report, the correct comment is now updated in follow up report as: this mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.Type of investigation in h.6 also missed to mention 10(testing of actual/suspected device), which correctly updated now.D.1 and d.2 sections were wrongly reported in the previous report, which are correctly updated in this follow up report.Pma/510(k) number in g.4 wrongly updated in previous report, which is correctly updated as k102465 in this follow up report.

• Brand Name: DREAMSTATION BIPAP AVAPS
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 13594748
• Report Number: 2518422-2022-06000
• Device Sequence Number: 17192101
• Product Code: MNS
• UDI-Device Identifier: 00606959043985
• UDI-Public: 00606959043985
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022
• 2 Devices were Involved in the Event: 1 2

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: 1060657
• Device Catalogue Number: 1060657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 12/04/2014
• Supplement Date Received by Manufacturer: 12/04/2014
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2011
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown