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

Model Number DS560TS

Device Problem Degraded (1153)

Patient Problems Arrhythmia (1721); Sore Throat (2396); Respiratory Tract Infection (2420); Taste Disorder (4422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging particles in tubing/chamber,nasal/throat irritation or soreness,atrial arrythmia,throat soreness,patient states has lost taste and smell related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 15086524
• MDR Text Key: 300707158
• Report Number: 2518422-2022-61482
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• 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 Sex: Male