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

Model Number CAX500T12

Device Problem Degraded (1153)

Patient Problem Ulcer (2274)

Event Date 10/27/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused the patient to be diagnosed with lesion on tongue.The patient did receive medical intervention in the form of a tongue biopsy.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: rod mell ; 6501 living place; pittsburgh, PA 15206 ; 7249003460
• MDR Report Key: 12817718
• MDR Text Key: 280873543
• Report Number: 2518422-2021-06715
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959026605
• UDI-Public: 00606959026605
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/15/2021

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: CAX500T12
• Device Catalogue Number: CAX500T12
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female