MAUDE Adverse Event Report: CHEMETRON AMVEX CORPORATION CHEMETRON ADAPTER DISS MALE OXY USA

Catalog Number AD-CHUO-DM

Device Problems Disconnection (1171); Gas Output Problem (1266); Device Slipped (1584); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2015

Event Type  malfunction  

Event Description

The connector separate from main body slowly with use.When you connect to the wall oxygen, it does not catch.This prevents the pt from getting full oxygen.This problem occurred overtime.It is a problem with the device as it wears but there wasn't a significant event that affected a pt.

• Brand Name: CHEMETRON ADAPTER DISS MALE OXY USA
• Type of Device: CHEMETRON ADAPTER DISS MALE OXY USA
• Manufacturer (Section D): CHEMETRON AMVEX CORPORATION
• MDR Report Key: 5129973
• MDR Text Key: 27674178
• Report Number: MW5056840
• Device Sequence Number: 1
• Product Code: CBO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 09/30/2015

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 Catalogue Number: AD-CHUO-DM
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Type of Device Usage: N
• Patient Sequence Number: 1