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

Model Number DS560TS

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Bronchitis (1752); Dyspnea (1816); Headache (1880); Dizziness (2194); Choking (2464); Taste Disorder (4422); Cough (4457); Unspecified Eye / Vision Problem (4471); Insufficient Information (4580)

Event Date 11/08/2022

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 cpap device's sound abatement foam.The manufacturer received information alleging of sickness, breathing problems, headaches, eye problems.There was no report of serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer has received new information regarding the device.Section b5 will 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 cpap device's sound abatement foam.The manufacturer received information alleging of sickness, breathing problems, headaches, eye problems, cough, choking, dizziness, bronchitis, asthma, tongue burning sensation, dryness.There was no report of serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Section b7 will be: the patient has esophagus issue.

• Brand Name: REMSTAR AUTO
• 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: 15714332
• MDR Text Key: 305008992
• Report Number: 2518422-2022-90103
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005907
• UDI-Public: 00606959005907
• 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,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS560TS
• Device Catalogue Number: DS560TS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female