MAUDE Adverse Event Report: VENTLAB LLC. AIRFLOW MANUAL RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number AF2242MBP

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2016

Event Type  malfunction  

Event Description

Customer states "the bags retaining co2 when we use the peep valve.We are getting high fico2 alarms when bagging with these bags w/peep applied.If we remove the peep valve the fico2 drops to 0 as it should.

• Brand Name: AIRFLOW MANUAL RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598350
• MDR Report Key: 5661007
• MDR Text Key: 45660405
• Report Number: 2246980-2016-00009
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF2242MBP
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/17/2016
• Type of Device Usage: N
• Patient Sequence Number: 1