MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTARAUTOA-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AH560HBT

Device Problem Degraded (1153)

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144); Dizziness (2194); Sore Throat (2396); Unspecified Respiratory Problem (4464)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device has not been yet returned to the manufacturer.

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 remstarautoa-flex device's sound abatement foam.The patient has alleged lung disease, dizziness and/or headache, nausea / vomiting, severe ear and throat inflammation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: REMSTARAUTOA-FLEX
• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19187282
• MDR Text Key: 341114950
• Report Number: 2518422-2024-22509
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959023925
• UDI-Public: 00606959023925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AH560HBT
• Device Catalogue Number: AH560HBT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other