MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMSTATION BIPAP AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1130T11C

Device Problem Degraded (1153)

Patient Problems Dry Eye(s) (1814); Headache (1880); Vomiting (2144); Sore Throat (2396); Dry Mouth (4485); Skin Disorders (4543)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

H3 other text: device not returned to manufacturer.

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 patient alleges headache, eye irritation, vomiting, skin irritation, dry mouth/nose, and sore throat.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION BIPAP AVAPS30
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17458719
• MDR Text Key: 320397419
• Report Number: 2518422-2023-18302
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045668
• UDI-Public: 00606959045668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1130T11C
• Device Catalogue Number: DSX1130T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1