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

Catalog Number H1

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/10/2018

Event Type  malfunction  

Event Description

Pt desaturated during breathing tx and on 8 lpm nc so total of 16 lpm o2 flow - pt desaturated to 80 percent; pt placed on autounit bipap h1 serial number (b)(4) with 15 lpm bleed in o2 and machine not working or delivering airflow.Error message "default call system administrator" pt immediately mbr 100 percent and 15 peep and during this transition pt sats dropped further to 74 percent and then came up to 94 percent with bagging; called for v60 unit; pt put on v60 bipap 15/8 100 percent sats up to 98 percent and abg drawn ph 7.19 co2 80; v60 bipap now on 20/8 100 percent.

• Brand Name: BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING
• Manufacturer (Section D): PHILLIPS
• MDR Report Key: 7442588
• MDR Text Key: 106206021
• Report Number: MW5076545
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: H1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 62 YR
• Patient Weight: 110