MAUDE Adverse Event Report: INVAMEX HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679; LIFT, PATIENT, NON-AC-POWERED

Model Number 9805P

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

The patient indicated that the lift has never been serviced.The maintenance safety inspection checklist within the portable patient lift and sling owner's manual indicates that on a monthly basis the casters and axle bolts should be inspected for tightness.If any parts are worn, they should be replaced immediately.The patient was referred to her provider for servicing and repair of the lift.Since the manufacture of this device, updates to the caster assembly design specifications and incoming inspection process have been implemented.The 9805p hydraulic lift was manufactured by invacare rehabilitation equipment co.(suzhou); however, they are no longer in business.The manufacture of these lifts has transitioned to invamex.

Event Description

The patient alleged that her aide was transferring her from the bed to the chair when a caster wheel fell off of the 9805p lift, and she fell to the floor onto her bottom.The patient stated that she hit her head on a piece of furniture and that she called 911 to help her up off the floor.The patient reported that the emts checked her for a concussion and other injuries but they found none, so she stayed home and did not go to the emergency room (er).

• Brand Name: HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 7099396
• MDR Text Key: 94288088
• Report Number: 9616091-2017-00007
• 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: Other
• Type of Report: Initial
• Report Date: 11/17/2017

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: Home Health Aide
• Device Model Number: 9805P
• Device Catalogue Number: 9805P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: 75