MAUDE Adverse Event Report: VENT LAB LLC / SUNMED HOLDINGS, LLC SUNMED VENTLAB PEEP VALVE; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Model Number VP703

Device Problem Output Problem (3005)

Patient Problem Death (1802)

Event Date 08/01/2019

Event Type  Death  

Event Description

A (b)(6) y/o female, gun shot to face and hip.Temporary use of ventlab peep valve malfunctioned at max level.Removed peep valve used another.

• Brand Name: SUNMED VENTLAB PEEP VALVE
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): VENT LAB LLC / SUNMED HOLDINGS, LLC; 2710 northridge dr nw, ste a; grand rapids MI 49544
• MDR Report Key: 8922997
• MDR Text Key: 155334015
• Report Number: MW5089263
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• 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: 08/05/2019

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: Health Professional
• Device Model Number: VP703
• Device Catalogue Number: VP703
• Device Lot Number: 318781
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 38 YR