MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSV ADV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 960P

Device Problem Degraded (1153)

Patient Problems Fatigue (1849); Sensitivity of Teeth (2427); Unspecified Eye / Vision Problem (4471)

Event Date 02/15/2018

Event Type  malfunction  

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 Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The reporter alleges patient having fluid in the eye, fatigue, toothache.The device was returned and there is evidence of dark-colored contaminants found in the bipap blower assembly during device evaluation.There was no allegation of serious or permanent harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

• Brand Name: BIPAP AUTOSV ADV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 13943184
• MDR Text Key: 288691482
• Report Number: 2518422-2022-06403
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959031968
• UDI-Public: 00606959031968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 960P
• Device Catalogue Number: 960P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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