MAUDE Adverse Event Report: PHILIPS HEALTHCARE NORTH AMERICAN V60; BIPAP

Model Number V60

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problems Dyspnea (1816); Cognitive Changes (2551)

Event Date 10/22/2015

Event Type  malfunction  

Event Description

This is an (b)(6) woman with a history of essential hypertension, diabetes mellitus, coronary artery disease, congestive heart failure, gastroesophageal reflux disease, dementia, failure to thrive who had a peg and was originally on home hospice for metastatic breast cancer who presented to ed with shortness of breath and significantly altered mental status.She had been maintained continuously on bipap.During the transport of the patient from ed to intermediate care the bipap screen said "vent in-op" x 2 while in transport.Patient placed on nc for rest of transport.Patient tolerated well on 02 at 5l/m.(b)(4).

• Brand Name: V60
• Type of Device: BIPAP
• Manufacturer (Section D): PHILIPS HEALTHCARE NORTH AMERICAN; 3000 minuteman rd.
• MDR Report Key: 5273141
• MDR Text Key: 32992209
• Report Number: MW5058349
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 59