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

Model Number CA561TS

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Angina (1710); Dizziness (2194)

Event Date 11/29/2021

Event Type  malfunction  

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 continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged having pain in the heart and lightheadedness.There was no report of patient harm/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 received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged having pain in the heart and lightheadedness.There was no report of serious patient harm or injury.The device was returned to the manufacturer's quality product investigation laboratory for investigation.Exterior investigation observed that the base unit did not have a ui knob present.The humidifier base corrosion present on both screws towards front and unknown dust/ dirt contamination was observed.Internal investigation of base unit found unknown dust/dirt contamination throughout the device internals.Dust contamination was observed in the blower, on the impeller, and sound abatement foam.Evidence of sound abatement foam degradation/breakdown was observed in this device.Internal investigation of the humidifier base shows unknown dust contamination throughout.Corrosion is present on three of the four screws.Heater plate discoloration present.The unknown dust/dirt contamination and fibers found on the blower casing/impeller and blower box was inconsistent with degraded sound abatement foam contamination.The presence of contamination throughout the airpath suggests a source external to the device.Investigation can confirm there was no evidence of sound abatement foam degradation/breakdown observed in the base unit but can confirm the presence of contamination in the airpath, likely from a source external to the device.

• 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: 15223035
• MDR Text Key: 301665763
• Report Number: 2518422-2022-65161
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959014169
• UDI-Public: 00606959014169
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CA561TS
• Device Catalogue Number: CA561TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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