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

Model Number FRX1130S14

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Headache (1880); Respiratory Tract Infection (2420); Cough (4457); Unspecified Respiratory Problem (4464); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging headaches; irritation of the eyes and throat; pressure in the chest; cough; difficulties alternating respiratory; sinusitis and stuffy nose related to a bipap device's sound abatement foam.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.

• Brand Name: DREAMSTATION AVAPS30
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14792926
• MDR Text Key: 302475775
• Report Number: 2518422-2022-50164
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/23/2022

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?: No
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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