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

Model Number 9805

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

End user's son stated that the lift is used in-home on a hard surface.He stated that the casters were performing correctly up until the failure, with no noticeable defects.He believed that the cause of the failure was due to the nut loosening over time, which weakened the bolt.He was not aware that the bolts needed to be periodically checked for tightness.He stated that he was unable to find the part required to fix the lift, so he and a machinist friend drilled out the hole and reset a new bolt.A capa was created to address caster failures such as broken/bent casters which resulted from incorrect bolt design specifications (proper bolt material not specified, bolt thread form not to specification, bolts not torqued sufficiently).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.There is no adjustment or maintenance 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." the manual contains a maintenance safety inspection checklist which identifies in-home to inspect/adjust monthly casters and axle bolts for tightness.The report does not allege that the device caused or contributed to a death or serious injury.However, based on established risk documentation, it has been determined that should the malfunction recur, the device would be likely to cause or contribute to a death or serious injury.Should additional information become available, a supplemental record will be filed.

Event Description

End user's son stated that his father was being transported in the lift when suddenly the caster bolt failed.He stated that it was bent at an approximately 30 degree angle.

• Brand Name: HYDRAULIC LIFT W/ADJ BASE 9153629360
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• 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 44035 ; 8003336900
• MDR Report Key: 6134910
• MDR Text Key: 61492623
• Report Number: 3008262382-2016-00654
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/01/2016

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: Lay User/Patient
• Device Model Number: 9805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/30/2016
• 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
• Patient Weight: 95