MAUDE Adverse Event Report: RESPIRONICS, INC OMNILAB ADVANCED PLUS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1111123
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
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 cpap device's sound abatement foam.There was no allegation of 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 in section b.2.Congenital anomaly/birth defect, in section d9 reported as device available for evaluation, in section h.3.It was marked in evaluation summary attached, in section d2 it was reported common device name as ventilator, non-continuous(respirator) and product code was reported as bzd and in g4, pma/ 510(k) number was reported as k131982.After review, it was determined no congenital anomaly/birth defect was reported ,this was incorrectly marked in section b.2.,in section d9 incorrectly reported as device available for evaluation, in section h.3 incorrectly marked on 'evaluation summary attached'., in d2 incorrectly reported common device name as ventilator, non-continuous(respirator) and product code was incorrectly reported as bzd and mistakenly in g4, pma/ 510(k) number was reported as k131982.The report should have been sent for product problem only in section b.1.D9 marked as no, section h3 was marked as no and evaluation summary was unckecked.In d2 device name was taken as ventilator, continuous, non-life-supporting.And product code was taken as mns.In e1 zip code was updated as 80239-2729.In g4, pma/ 510(k) number was taken as k090539.
Additional Manufacturer Narrative
The manufacturer previously marked h10 incorrectly.This mdr was not 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.

• Brand Name: OMNILAB ADVANCED PLUS
• 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: 13961713
• Report Number: 2518422-2022-05370
• Device Sequence Number: 11931239
• Product Code: MNS
• UDI-Device Identifier: 00606959029392
• UDI-Public: 00606959029392
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2022
• 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: 1111123
• Device Catalogue Number: 1111123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 08/04/2021
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/13/2022; 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2017
• 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: Congenital Anomaly
• Patient Sex: Unknown