MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1130H11C

Device Problem Degraded (1153)

Patient Problems Breast Cancer (1759); Headache (1880); Epistaxis (4458)

Event Date 04/14/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged breast cancer, nose bleeds, and headaches while using the device.Medical intervention was not specified.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 received an issue related to a bipap device's sound abatement foam alleging breast cancer, nose bleeds, and headaches while using the device.Medical intervention was not specified.Despite of three attempts 08/01/2022, 08/04/2022, 08/08/2022 ; 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.

• Brand Name: DREAMSTATION BIPAP AVAPS30
• 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: 14315881
• MDR Text Key: 291213376
• Report Number: 2518422-2022-17991
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045651
• UDI-Public: 00606959045651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• 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,Followup
• Report Date: 08/19/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: DSX1130H11C
• Device Catalogue Number: DSX1130H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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
• Patient Outcome(s): Other