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

Model Number	567P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of an allegation that a new user reported an upper respiratory tract infection after using his cpap device for 10-15 days.He received an injection at his hospital consultation due to his general discomfort.After two more additional trials of cpap of therapy for 10 days, the user experienced the same symptoms, despite having his machine checked out and adjusted.His physician suggested to stop using the device.The manufacturer has requested the return of the device.The investigation is on-going.On completion of the manufacturer's investigation, a follow up report will be filed.
Additional Manufacturer Narrative
Section h10 was captured incorrectly in the previous report.It should be reported as:  the manufacturer became aware of an allegation that a new user reported an upper respiratory tract infection after using his cpap device for 10-15 days.He received an injection at his hospital consultation due to his general discomfort.After two more additional trials of cpap of therapy for 10 days, the user experienced the same symptoms, despite having his machine checked out and adjusted.His physician suggested to stop using the device.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 and unit is scrapped.Section h1: type of reportable event was captured incorrectly in the previous report as a malfunction.It has been corrected serious injury in this report.Sections h7 and h9 were missed in the initial report.They have been updated and corrected in this report. .
Additional Manufacturer Narrative
The manufacturer became aware of an allegation that a new user reported an upper respiratory tract infection after using his cpap device for 10-15 days.He received an injection at his hospital consultation due to his general discomfort.After two more additional trials of cpap of therapy for 10 days, the user experienced the same symptoms, despite having his machine checked out and adjusted.His physician suggested to stop using the device.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 and unit is scrapped.Section h3: type of reportable event was captured incorrectly in the previous report as a malfunction.It has been corrected serious injury in this report.  in this report, section d9, g3, h3, h6 has been updated.

• Brand Name: REMSTAR AUTO, CN
• Common Device Name: 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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12931946
• Report Number: 2518422-2021-07715
• Device Sequence Number: 5761054
• Product Code: BZD
• UDI-Device Identifier: 00606959031142
• UDI-Public: 00606959031142
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 08/28/2023; Not provided
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 03/21/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male