MAUDE Adverse Event Report: GE INNOVA; ANGIOGRAPHY TABLE

Model Number 4100

Device Problem Protective Measures Problem (3015)

Patient Problems Death (1802); Fall (1848); Bone Fracture(s) (1870)

Event Date 10/31/2014

Event Type  Death  

Event Description

Inpatient transferred to angiography procedure table for picc line placement, left and right arm boards positioned.Pt rolled off table onto floor.Review of event revealed that there were no safety belts for equipment and no place to attach belts to table.Pt was transferred to the emergency department for evaluation and acute injury interventions.

Event Description

Additional information received from reporter (b)(4) 2015: pt was then transferred to (b)(6) for treatment of injuries.On (b)(6) 2015 (b)(6) obtained a copy of the autopsy.The autopsy named the cause of death as complications of congestive heart failure, contributory conditions as "hypertensive and arteriosclerotic cardiovascular disease, obesity, bronchiectasis, multiple blunt force injuries, and listed the manner of death as "accident" (fell to floor during medical procedure).

• Brand Name: INNOVA
• Type of Device: ANGIOGRAPHY TABLE
• Manufacturer (Section D): GE; milwaukee
• MDR Report Key: 4270190
• MDR Text Key: 5029788
• Report Number: MW5039148
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4100
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 88