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

Model Number CAX501H12

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Pleural Effusion (2010); Pulmonary Edema (2020)

Event Date 08/20/2021

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 a patient to develop water in their lungs.The patient was hospitalized in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop water in their lungs.The patient was hospitalized in response to the reported event.In this initial report section b5 was incorrect, the correct b5 should be - the patient has alleged water in their lungs and difficulty breathing/short of breath.The patient was hospitalized in response to the reported event.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of device was completed by the manufacturer and found evidence of unknown white deposits in filter inlet, unknown debris with dust in the bottom of the inside of device, unknown white debris with dust found on top of blower.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The device was applied power and the device operated properly.The manufacturer concludes multiple contaminates found were inconsistent with sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation.In this report, section d9, g3, h6 have been updated/corrected.

• Brand Name: DREAMSTATION EXPERT
• 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: 13051890
• MDR Text Key: 282555190
• Report Number: 2518422-2021-08503
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959053168
• UDI-Public: 00606959053168
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX501H12
• Device Catalogue Number: CAX501H12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2020
• 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): Hospitalization