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

Model Number VP703

Device Problem Gas/Air Leak (2946)

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

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

The product was found to function as intended upon receipt of the suspect product.The device was tested with multiple resuscitation bags and found to function as intended when utilizing a calibrated test lung.Complaint was not confirmed.

Event Description

The customer alleges that "the therapist removed the valve when bagging the patient for an intubation.The ambu bag became hard to squeeze.When he removed the peep valve there was a big gush of air release and they could then bag the patient easily." no other details were provided and no patient injury/harm reported.

• Brand Name: VENTLAB
• Type of Device: PEEP VALVE
• Manufacturer (Section D): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids, mi
• MDR Report Key: 9810548
• MDR Text Key: 193587293
• Report Number: 1314417-2020-00014
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• 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: 316764
• Type of Device Usage: N
• Patient Sequence Number: 1