MAUDE Adverse Event Report: UNKNOWN HYDRAULIC LIFT W/LOW BASE-PLUS 9153633521; LIFT, PATIENT, NON-AC-POWERED

Model Number UNKNOWN

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The caller alleges that the sling on a unknown lift is coming apart at the seam where the loop meets the fabric.

• Brand Name: HYDRAULIC LIFT W/LOW BASE-PLUS 9153633521
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4333526
• MDR Text Key: 5215591
• Report Number: 1525712-2014-08659
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other