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

Model Number 567P

Device Problem Insufficient Information (3190)

Patient Problem Respiratory Tract Infection (2420)

Event Date 11/04/2021

Event Type  Injury  

Event 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.

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
• 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: 12931946
• MDR Text Key: 281742974
• Report Number: 2518422-2021-07715
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959031142
• UDI-Public: 00606959031142
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 567P
• Device Catalogue Number: 567P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male