BIPAP VISION 582059 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-29 for BIPAP VISION 582059 * manufactured by Respironics, Inc..

Event Text Entries

[19419491] Attempted to change the mode on the bipap already in use by the patient. The machine would not allow the change to be made. What was the original intended procedure? Patient was already in distress and the practitoner attempted to change the mode on the bipap machine. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3171893
• MDR Report Key: 3171893
• Date Received: 2013-05-29
• Date of Report: 2013-05-29
• Date of Event: 2013-02-16
• Report Date: 2013-05-29
• Date Reported to FDA: 2013-05-29
• Date Reported to Mfgr: 2013-06-17
• Date Added to Maude: 2013-06-17
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIPAP VISION
• Generic Name: ATTACHMENT, BREATHING, POSITIVE AND EXPIRATORY
• Product Code: BYE
• Date Received: 2013-05-29
• Model Number: 582059
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1010 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-05-29