MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. BIPAP A30S; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Temperature Problem (3022)

Patient Problem Eye Burn (2523)

Event Date 10/14/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap a30s water boiled in the humidifier and hot steam burned the patient's face and left eye.The cornea of the left eye was damaged and required a new cornea implantation.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a bipap a30s water boiled in the humidifier and hot steam burned the patient's face and left eye.The cornea of the left eye was damaged and required a new cornea implantation.Despite the three attempts to have the device returned for evaluation and investigation were unsuccessful.The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: BIPAP A30S
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12738431
• MDR Text Key: 279599695
• Report Number: 2518422-2021-06148
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1