MAUDE Adverse Event Report: INVACARE TAYLOR ST. HYDRAULIC LIFT W/ADJ BASE 9153629360; NON-AC POWERED PATIENT LIFT

Model Number NA:9805

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned and no return is expected.The complaint of the lift having a bent caster could not be confirmed.The dealer was unable to provide any additional information.There have been no replacement parts ordered at this time.Should additional information become available, a supplemental record will be filed.The portable patient lift and sling owner's manual states, "casters and axle bolts require inspections every six months to check for tightness and wear" and "there is no adjustment or maintenance to the casters, other than cleaning, lubrication and checking axle and swivel bolts for tightness.Remove all debris, etc.From the wheel and swivel bearings.If any parts are worn, replace these parts immediately.".

Event Description

The caller states she doesn't have the serial number of the lift, but states one of the casters is bent.

• Brand Name: HYDRAULIC LIFT W/ADJ BASE 9153629360
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR ST.; 1200 taylor st.; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6463397
• MDR Text Key: 71896693
• Report Number: 1531186-2017-00007
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: NA:9805
• Device Catalogue Number: 9805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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