MAUDE Adverse Event Report: PRECISION MEDICAL, INC. CHEMETRON - MF QUICK CONNECT GAS WALL OUTLETS; CHEMETRON QUICK CONNECT - O2

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 06/29/2014

Event Type  malfunction  

Event Description

While performing care during a resuscitation of an infant, the oxygen hose spontaneously dislodged from oxygen outlet and metal adapter, striking the employee in the chest with force.Employee not injured due to strike being in a padded area of body.Note: chemetron adapter at end of oxygen hose was plugged into an o2 coupler wye.

• Brand Name: CHEMETRON - MF QUICK CONNECT GAS WALL OUTLETS
• Type of Device: CHEMETRON QUICK CONNECT - O2
• Manufacturer (Section D): PRECISION MEDICAL, INC.; 300 held drive; northampton PA 18067
• MDR Report Key: 3986437
• MDR Text Key: 4751941
• Report Number: 3986437
• Device Sequence Number: 1
• Product Code: BYX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYGEN WYE