MAUDE Adverse Event Report: GE HEALTHCARE OEC; C-ARM

Model Number BRIVO

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pneumothorax (2012)

Event Date 05/16/2017

Event Type  Injury  

Event Description

Physician was performing bronchoscopy, fluro machine blanked out and when it came back on the biopsy forcep was thru the lung, causing a pneumothorax.

• Brand Name: OEC
• Type of Device: C-ARM
• Manufacturer (Section D): GE HEALTHCARE; waukesha WI 53188
• MDR Report Key: 6587047
• MDR Text Key: 75969448
• Report Number: MW5069977
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2017

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 Model Number: BRIVO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Weight: 68