MAUDE Adverse Event Report: VENTLAB VENTLAB; RESUSCITATOR

Model Number AF 5000 SERIES

Device Problem Misconnection (1399)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/22/2015

Event Type  Injury  

Event Description

The pt upon arrival in critical care was placed on a cardiac monitor which displayed pea.Cpr initiated; resuscitation efforts successful.During transport from pacu to critical care post recovery.The ambu bag was connected to the filter of the expiration port and not the inhalation port.This was discovered upon arrival in critical care by respiratory therapy.Pt remains unresponsive and ventilated.Documented in progress notes by the physician, pt has anoxic encephalopathy.

• Brand Name: VENTLAB
• Type of Device: RESUSCITATOR
• Manufacturer (Section D): VENTLAB
• MDR Report Key: 4866244
• MDR Text Key: 5810382
• Report Number: MW5043196
• Device Sequence Number: 2
• Product Code: BTM
• 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: 06/08/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AF 5000 SERIES
• Device Catalogue Number: AF 5000 SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 73 YR