MAUDE Adverse Event Report: VITAL SIGNS EDITH1000

Model Number A8E520AX

Device Problems Defective Device (2588); Material Deformation (2976)

Patient Problem Hypoventilation (1916)

Event Date 12/29/2014

Event Type  Injury  

Event Description

Ge vital signs edith1000 heat/moisture filter (a component of vitalsigns adult circle breathing circuit lot 10293827 - ge medical systems (b)(6)) device failed during use, resulting in failure to ventilate patient.This is one of numerous failures of the same product in past 3 weeks other examples of the same lot identified as faulty visual inspection reveals imperfections in injection-moulded housing - it is suspected that reprocessed/recycled plastic was used in manufacture.

• Brand Name: EDITH1000
• Type of Device: EDITH1000
• Manufacturer (Section D): VITAL SIGNS; totowa NJ 07512
• MDR Report Key: 4379902
• MDR Text Key: 5258425
• Report Number: MW5039890
• Device Sequence Number: 1
• Product Code: BYD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A8E520AX
• Device Lot Number: 10293827
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 63