MAUDE Adverse Event Report:; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 02/23/2007

Event Type  malfunction  

Event Description

Ventilator circuit was being changed to a heated circuit when the heater malfunctioned.The heater probe was touched and a shock was given to the respiratory therapist.Probe was faulty.

• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• MDR Report Key: 7381579
• MDR Text Key: 103988667
• Report Number: 7381579
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2007,02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2007
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2007
• Type of Device Usage: N
• Patient Sequence Number: 1