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

Model Number DSX700H11C

Device Problem Degraded (1153)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Headache (1880); Nausea (1970); Dizziness (2194); Sore Throat (2396)

Event Date 04/21/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused diarrhea, nausea, abdominal pain and dizziness.The patient did report to receive medical intervention and is on medication.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 information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no patient harm or injury.B5- additional information was received on different dates reporting headaches, nasal and throat irritation/soreness.G3-corrected bad to the latest date additional information was received.H6-health effect clinical code(s) were added to reflect additional information.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 14345606
• MDR Text Key: 291285109
• Report Number: 2518422-2022-19114
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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): Required Intervention; Other