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

Model Number DS560TS

Device Problems Degraded (1153); Device Emits Odor (1425); Appropriate Term/Code Not Available (3191)

Patient Problem Dyspnea (1816)

Event Date 01/24/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to cpap device's sound abatement foam.The patient alleged breathing difficulty / short of breath.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 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 device will not turn on/device not functioning, burning/smoke/electrical odor and difficulty breathing/short of breath related to a cpap device's sound abatement foam.There was no report of patient harm or injury.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 a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section a3 (gender) was updated.Section h6 updated in this report.

• Brand Name: REMSTAR AUTO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, pa, PA 15206 ; 2673970028
• MDR Report Key: 15107059
• MDR Text Key: 300788287
• Report Number: 2518422-2022-61101
• 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: 06/07/2023

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: 01/24/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2014
• 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: Female