MAUDE Adverse Event Report: GFWA MEDICAL LIFT SYSTEM

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Sepsis (2067); Tissue Damage (2104); Quadriplegia (2449)

Event Date 03/14/2014

Event Type  Death  

Event Description

The decedent became angled in his medical lift system.The remote to operate the device was attached to something and may have been out of his reach.His arm may have been stuck in part of the lift which led to rhabdomyolysis.He was stuck for several hours before being discovered.He was thought to the hospital and diagnosed with rhabdomyolysis.He also had urosepsis.He has a history of incomplete quadriplegia which is the reason he was using the lift to transport himself around his residence.He was admitted to (b)(6) hospital.

• Brand Name: MEDICAL LIFT SYSTEM
• Type of Device: MEDICAL LIFT SYSTEM
• Manufacturer (Section D): GFWA
• MDR Report Key: 3727542
• MDR Text Key: 4276547
• Report Number: MW5035439
• Device Sequence Number: 2
• Product Code: FNG
• 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: 03/27/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 119