MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900T11C

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Headache (1880); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Vomiting (2144); Dizziness (2194); Unspecified Hepatic or Biliary Problem (4493); Unspecified Kidney or Urinary Problem (4503)

Event Date 03/21/2024

Event Type  Injury  

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 dreamstation bipap autosv device's sound abatement foam.The patient has alleged asthma (new or worsening), eye irritation, dizziness and/or headache, hypersensitivity, nausea / vomiting, kidney disease/toxicity and liver disease/toxicity.Medical intervention was not specified.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The exact recall number is unknown.Possible recall numbers include z-1972, z-1973 and z-1974.H3 other text : not returned to manufacturer.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19061595
• MDR Text Key: 339616789
• Report Number: 2518422-2024-18071
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• 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: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2019
• 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