MAUDE Adverse Event Report: VENTLAB A SUNMED BRAND VENTLAB A SUNMED BRAND; AIRFLOW MANUAL RESUSCITATOR/VENT

Lot Number 304805

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problem No Information (3190)

Event Date 07/06/2016

Event Type  Injury  

Event Description

Manual resuscitation/ventilator bag prepared with mask and patient bag/mask ventilated.Upon intubation of patient, respiratory therapist was unable to disconnect mask from the bag valve in order to ventilate via endotracheal tube.Required an unreasonable amount of effort to separate mask from bag valve.

• Brand Name: VENTLAB A SUNMED BRAND
• Type of Device: AIRFLOW MANUAL RESUSCITATOR/VENT
• Manufacturer (Section D): VENTLAB A SUNMED BRAND; grand rapids MI 49544
• MDR Report Key: 5808420
• MDR Text Key: 50079337
• Report Number: MW5063527
• Device Sequence Number: 1
• Product Code: BTM
• 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: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 304805
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 74 YR