MAUDE Adverse Event Report: GE HEALTHCARE, LLC INNOVA 3100; CARDIOVASCULAR IMAGING SYSTEM - TABLE

Model Number ZJ0000MG

Device Problems Crack (1135); Device Tipped Over (2589)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2017

Event Type  malfunction  

Event Description

During a vascular catheterization procedure in the cath lab, the table the patient was lying on cracked.As the portion of the table slowly tilted down, the patient slid slowly onto the floor with the pad and pillow still in place.The tech carefully lowered the patient into her lap.The patient weight did not exceed the 450 pound table limit.The patient was unharmed.

• Brand Name: INNOVA 3100
• Type of Device: CARDIOVASCULAR IMAGING SYSTEM - TABLE
• Manufacturer (Section D): GE HEALTHCARE, LLC; wauwatosa WI
• MDR Report Key: 6717701
• MDR Text Key: 80291902
• Report Number: MW5071012
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/13/2017

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: ZJ0000MG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 98