MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSV ADV; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DE962S

Device Problem Degraded (1153)

Patient Problems Epistaxis (4458); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient has alleged to seeing a heavily soiled device, pollution in the air intake, low pressure error message, black soot in the nose.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 previously reported an allegation of an issue related to a bipap device's sound abatement foam.The patient has alleged to seeing a heavily soiled device, pollution in the air intake, low pressure error message, black soot in the nose.There was no report of patient harm or injury.The reporter also alleged of nose bleeds.Despite multiple attempts on 7/18/2022, 7/14/2022, 7/08/2022, the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Section h6 updated in this report.

• Brand Name: BIPAP AUTOSV ADV
• 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: 14489685
• MDR Text Key: 300361722
• Report Number: 2518422-2022-25125
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959029682
• UDI-Public: 00606959029682
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: DE962S
• Device Catalogue Number: DE962S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2013
• 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