MAUDE Adverse Event Report: US SURGICAL PUERTO RICO VENTLAB; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Model Number VP703

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, suture breakage was observed on two devices during surgery, in 3 different occasions.There was no patient injury.

• Brand Name: VENTLAB
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8656740
• MDR Text Key: 146900704
• Report Number: 2647580-2019-02783
• Device Sequence Number: 1
• Product Code: BYE
• UDI-Device Identifier: 10889483105597
• UDI-Public: 10889483105597
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1