MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AVAPS30 AAM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number FRX1130S14

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Headache (1880); Lethargy (2560); Unspecified Respiratory Problem (4464)

Event Date 08/24/2021

Event Type  malfunction  

Event Description

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 received information alleging of headache,sleepiness and cold.There was no report of serious or permanent patient harm or injury.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 information 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 patient alleged headache, fatigue, and a head cold while using the device.There was no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer's product investigation laboratory for investigation.External investigation found an unknown contaminant on both ends of the ac power cord and parts of the dc power supply.No evidence of damage, degradation, or contamination were observed on the exterior of the unit itself.Internal investigation by the manufacturer found minor to moderate dust contamination in the air intake, blower box and blower.Prodcut investigation lab also observed a minor deformation of the pressure sensor seal.The deformation does not appear to have impacted sensor function and appears to have been caused either by compression with a sharp cornered object or from manufacturing defect.Product investigation lab failed to observe any evidence of foam degradation, damage, or contamination.Product investigation lab applied power and verified the unit provided airflow.The device's downloaded event log was reviewed by the manufacturer and found 0 errors logged.The manufacturer was unable to confirm the customer's complaints.The manufacturer confirmed there was no evidence of sound abatement foam degradation.Please see sections h3 and h6 for this updated coding and information.

• Brand Name: DREAMSTATION AVAPS30 AAM
• 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: 15455199
• MDR Text Key: 304008318
• Report Number: 2518422-2022-81326
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FRX1130S14
• Device Catalogue Number: FRX1130S14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• 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