MAUDE Adverse Event Report: RESPIRONICS INC DREAMSTATION AUTOSV, FR; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number FRX900S14

Device Problem Degraded (1153)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/08/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to develop eye issues.The patient did receive medical intervention in the form of prescription for opthalmic drops and antibiotics.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

• Brand Name: DREAMSTATION AUTOSV, FR
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• Manufacturer (Section G): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• Manufacturer Contact: rod mell ; 6501 living place; pittsburgh, PA 15206 ; 7249003460
• MDR Report Key: 12737233
• MDR Text Key: 279556840
• Report Number: 2518422-2021-06123
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959043503
• UDI-Public: 00606959043503
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/21/2021

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: FRX900S14
• Device Catalogue Number: FRX900S14
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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
• Patient Age: 77 YR