MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AVAPS C-SERIES; VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING

Model Number IT1161S

Device Problem Degraded (1153)

Patient Problems Headache (1880); Skin Inflammation/ Irritation (4545)

Event Date 07/23/2021

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned for evaluation.

Event Description

The manufacturer became aware of a user of a bipap avaps c series device was experiencing headaches and skin irritation, especially of the head since (b)(6) 2021.There was no report of visible particles seen of any kind.The device is currently at the patient's home.The product has not been returned for investigation.The manufacturer's investigation is on-going.A follow up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP AVAPS C-SERIES
• 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 15208 ; 4125423300
• MDR Report Key: 17908724
• MDR Text Key: 325351180
• Report Number: 2518422-2023-26200
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959048171
• UDI-Public: 00606959048171
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102465
• 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

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: IT1161S
• Device Catalogue Number: IT1161S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1