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

Model Number NA:9805

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

The complaint of the caster breaking off could not be confirmed.  the end user stated they did not know how the caster broke.They were referred to a provider, replacement parts were ordered and shipped.The product has not been returned.There was no alleged patient involvement.The end user just wanting the lift repaired.No pictures were provided.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 end user states that the right rear locking caster is broken.The caller does not know how it broke.

• Brand Name: HYDRAULIC LIFT W/ADJ BASE 9153629360
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou, jiangsu 21512 1; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou, jiangsu 21512 1; CH 215121
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6574968
• MDR Text Key: 75429691
• Report Number: 3008262382-2017-00007
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/21/2017

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: Other Caregivers
• Device Model Number: NA:9805
• Device Catalogue Number: 9805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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