MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679; LIFT, PATIENT, NON-AC POWERED

Model Number NA:9805P

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation, so the alleged failure of the caster bending was not able to be verified.Maintenance records for the device were not available for review.Multiple attempts have been made to obtain further information concerning the event without success.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." should additional information become available, a supplemental record will be filed.

Event Description

The caller stated that they were moving the patient in the lift and the lift tipped with the patient.The caller stated they did call emergency services and they helped the patient back into bed.No additional attention was sought.The caller stated the left back caster is bent.The caller stated the wheel is the left back wheel.

• Brand Name: HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679
• 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: 6241251
• MDR Text Key: 64581204
• Report Number: 3008262382-2017-00001
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:9805P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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
• Patient Age: 43 YR
• Patient Weight: 114