MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. VENTLAB; PEEP VALVE

Model Number VP703

Device Problem Defective Device (2588)

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

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

The affected device was returned in a bioburden bag, therefore the spring could not be functionally tested.Thirteen devices from inventory were functionally tested for cap rotation and spring movement.Each device performed as expected.Investigation is inconclusive.

Event Description

The customer alleges that "peep valve locked up and would not allow for exhalation during bagging".

• Brand Name: VENTLAB
• Type of Device: PEEP VALVE
• Manufacturer (Section D): SUNMED HOLDINGS, LLC.; 2710 northridge dr. nw.; suite a; grand rapids MI 49544
• MDR Report Key: 8955386
• MDR Text Key: 191468953
• Report Number: 1314417-2019-00047
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• PMA/PMN Number: K961867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VP703
• Device Lot Number: 318781
• Type of Device Usage: N
• Patient Sequence Number: 1