MAUDE Adverse Event Report: BIPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problems Increase in Pressure (1491); Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Dyspnea (1816); Swelling/ Edema (4577)

Event Date 05/07/2022

Event Type  Death  

Event Description

My mother was patient and the bipap device was used.She complained about the device to nurse and doctors.She said there was too much air flow pressure and she couldn't breathe, it also caused bruises and swelling near eye and face.I believe it suffocated her.She told them if they used it again on her that it would kill her.They had to restrain her from taking it off.Something in the bipap device caused the air flow issues.This happened in the icu at (b)(6) hospital in (b)(6).Please investigate this.She died on (b)(6) 2022.My mother was 85 and she tried to tell them in her own words that something was wrong with the bipap device and the way the hospital staff administered the device.Fda safety report id# (b)(4).

• Brand Name: BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• MDR Report Key: 15805851
• MDR Text Key: 303806782
• Report Number: MW5113286
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/12/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death; Life Threatening
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American