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

Model Number CA221HS

Device Problems Degraded (1153); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to the device getting hot and blowing hot air.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

Upon further review, the device not contain sound abatement foam that would be likely to cause or contribute to death or serious injury and is not in scope of res 88058.Therefore, there is no allegation of a reportable event associated with the device at this time.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Section h6 medical device problem code was coded incorrectly on the previous report.

• Brand Name: REMSTAR SE
• 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: 14046357
• MDR Text Key: 298154623
• Report Number: 2518422-2022-12452
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959020078
• UDI-Public: 00606959020078
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CA221HS
• Device Catalogue Number: CA221HS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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