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

Model Number DS560HS

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Blurred Vision (2137)

Event Date 08/03/2021

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 cpap device's sound abatement foam.The patient has alleged to having blurred vision.   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.

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 visualization of particles 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 h6 updated in this report.

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 reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged blurred vision.There was no report of serious or permanent harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.Upon external/internal examination, pil observed a black substance, consistent with sound abatement foam degradation, was observed on the underside of the blower box top, blower box motor, blower box and outside blower box.Pil observed that the sound abatement foam at the bottom of the enclosure visibly shows that it is degraded with cracks and has visible signs of moisture on the foam.Secondary findings are right panel assembly, the air outlet port, top lid underside and outside and in the inside of the air inlet hole, pca and ui display, around the ui rotary switch and on top of u1 had dust-like contamination on them.Pca j5 copper pins had unknown black contamination on them.Outlet port of the side panel has dust-like contamination on it.Water tank has slight unknown contamination on the tank pan.Unknown dust-like contamination on the bottom of the enclosure and the heater plate.Dry box seal had yellowed and has unknown contamination on it.Bottom of the enclosure and under the heater plate has dust-like contamination and potential tiny fibers.Pil can confirm the presence of multiple contaminants that are not consistent with degraded sound abatement foam from the secondary findings.The device's downloaded event log was reviewed by the manufacturer and found 9 errors.The manufacturer concludes the device has contamination and there was evidence of sound abatement foam degradation.In previous report section h10 mentioned incomplete, correct h10 should be - the patient alleged blurred vision related to a cpap device's sound abatement foam.There was no report of patient harm or injury.Corrected information was provided in d1, d4, g4 (device model, catalog, serial number, udi number, 510k number and device manufacture date were updated in this report).

• Brand Name: REMSTAR AUTOA-FLEX
• 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: 15696354
• MDR Text Key: 304912929
• Report Number: 2518422-2022-88690
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005891
• UDI-Public: 00606959005891
• 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,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS560HS
• Device Catalogue Number: DS560HS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• 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