MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A30-S SILVER SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1111150
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Sleep Dysfunction (2517); Cough (4457); Unspecified Eye / Vision Problem (4471); Unspecified Kidney or Urinary Problem (4503); Cramp(s) /Muscle Spasm(s) (4521); Skin Disorders (4543)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
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 to experiencing inflammation in the hands, knee, feet, chest, coughing attacks, muscle pain, leg cramps, problems with the eyes, urinary tract inflammation, sleep disorders and skin disorders.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.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 was previously reported in reference to voluntary field safety notice / recall an allegation of an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient has alleged to experiencing inflammation in the hands, knee, feet, chest, coughing attacks, muscle pain, leg cramps, problems with the eyes, urinary tract inflammation, sleep disorders and skin disorders.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The manufacturer received information 01/19/2022 that the customer's lawyer refuses to send the device to the manufacturer for examination and is considering initiating judicial evidence preservation proceedings.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: BIPAP A30-S SILVER SERIES
• 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: 15380954
• Report Number: 2518422-2022-80369
• Device Sequence Number: 5707367
• 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,Consumer,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 1111150
• Device Catalogue Number: 1111150
• 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: 11/30/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2019
• 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