MAUDE Adverse Event Report: RESPIRONICS REMSTARAUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DS560TBT

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Dyspnea (1816); Sore Throat (2396); Eye Burn (2523); Cough (4457); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.There was no report of patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.A correction to b5 was made and should 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 previously received information alleging visualization of particles related to a cpap device's sound abatement foam.The patient also alleged having cough with mucus, nose runs, burning eyes, having trouble breathing, sinus infection and also pain in chest.Response to the reported events patient was advised to take very powerful antibiotic.The reported event is assessed as possibly related to the device in this case.This reported event may possibly have resulted from the usage of the device due to foam degradation or/and emission of voc from the sound abatement foam.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section b1, b2 was updated to reflect adverse event and product problem.Section h1 was updated to reflect serious injury.Section h6-health effect-clinical code, impact code, type of investigation, investigation findings and conclusion have been updated in this report.

• Brand Name: REMSTARAUTO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13059041
• MDR Text Key: 282611503
• Report Number: 2518422-2021-08563
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030510
• UDI-Public: 00606959030510
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/04/2023

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: DS560TBT
• Device Catalogue Number: DS560TBT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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