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

Model Number	567P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Event or Problem Description
The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.There was no allegation of harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously marked additional manufacturer narrative incorrectly.This mdr was not submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints discovered as part of a retrospective remediation review.
Additional Manufacturer Narrative
Additional information was received on sep 15, 2023 and section h11 should be reported as: the manufacturer previously received information alleging an issue related to a bipap device's sound abatement foam.There was no report of serious patient harm or injury.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were four errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Device was scrapped.

• Brand Name: REMSTAR AUTO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer Contact: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 13771964
• Report Number: 2518422-2022-08720
• Device Sequence Number: 17409098
• Product Code: BZD
• UDI-Device Identifier: 00606959031142
• UDI-Public: 00606959031142
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 567P
• Device Catalogue Number: 567P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 09/06/2021; 09/15/2023
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 07/12/2022; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown