MAUDE Adverse Event Report: BIPAP V60; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT FACILITY USE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 04/15/2019

Event Type  Injury  

Event Description

Peak inspiratory pressure on bipap v60 was not correlating with the set ipap.Machine was displaying 14 cmh20 instead of 20 cmh20 or greater.There were no leaks in the system.Fda safety report id# (b)(4).

• Brand Name: BIPAP V60
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT FACILITY USE
• MDR Report Key: 8536179
• MDR Text Key: 142774019
• Report Number: MW5086038
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 58