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

Model Number CAX1130H12C

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Unspecified Kidney or Urinary Problem (4503)

Event Date 10/08/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap).Device's sound abatement foam became degraded and caused the patient to have shortness of breath and kidney infection.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 was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging issue related to a bipap device's sound abatement foam.Patient alleged having occasionally pain in throat.Muscular pain, difficulty breathing when using machine.Patient was in the hospital for 3 days for kidney infection.Patient was prescribed antibiotics, has sinus issues.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this updated report will be filed.Corrected information provided in b5, the information (patient alleged having occasionally pain in throat.Muscular pain.Patient was prescribed antibiotics, has sinus issues) was not included in initial report.

• 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: 13064894
• MDR Text Key: 283833946
• Report Number: 2518422-2021-08548
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045712
• UDI-Public: 00606959045712
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102465
• 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,Followup
• Report Date: 07/18/2023

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: CAX1130H12C
• Device Catalogue Number: CAX1130H12C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2017
• 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): Hospitalization
• Patient Sex: Male