MAUDE Adverse Event Report: RESPIRONICS INC BIPAP A30-S SILVER SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1111150
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Sore Throat (2396); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to the fda per 21 cfr part 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously received information alleging an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam.There was no report of patient harm or injury.In the initial report, section b5 was incorrect, the correct b5 should be- 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 an issue related to a bipap device's sound abatement foam.The patient has alleged discomfort in the oropharyngeal area.There was no report of serious patient harm or injury.Clinical code in h6 section was incorrect in the previous report.The device was returned to the manufacturer's product investigation laboratory for investigation.An external visual inspection was completed by the manufacturer.The manufacturer found no evidence of contamination.An internal visual inspection of the device was completed by manufacturer.The manufacturer found dust and debris contamination on the air inlet filter and in some other areas, water ingress on the inside of the enclosure.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The manufacturer concludes the contaminates found were consistent with water ingress, dust and debris contamination.The manufacturer confirmed there was no evidence of sound abatement foam degradation.The device passed all final testing.

• Brand Name: BIPAP A30-S SILVER SERIES
• 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: 12245286
• Report Number: 2518422-2021-02581
• Device Sequence Number: 5244662
• Product Code: MNS
• UDI-Device Identifier: 00606959039360
• UDI-Public: 00606959039360
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2023

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: 1111150
• Device Catalogue Number: 1111150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 06/06/2023
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/16/2021; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEATED HUMIDIFIER SN (B)(6); HEATED HUMIDIFIER SN B2144923491B6
• Patient Sex: Unknown