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

Model Number 1111150

Device Problem Degraded (1153)

Patient Problems 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)

Event Date 11/30/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 303224180
• Report Number: 2518422-2022-80369
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959039360
• UDI-Public: 00606959039360
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1111150
• Device Catalogue Number: 1111150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1