MAUDE Adverse Event Report: INVAMEX INVACARE RELIANT 600 HEAVY-DUTY POWER LIFT WITH MANUAL LOW BASE; LIFT, PATIENT, AC-POWERED

Model Number RPL600-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

There was no alleged defect or malfunction with the lift.The device was not being used at the time of the incident; it was left unattended in the facility's hallway.The facility advised that the patient is ambulatory, but they may not have the mental cognitive ability to understand that they should not walk into the lift.The product will not be returned to invacare for an evaluation.The facility maintenance director stated that they are not in possession of the hanger assembly, and they are not aware of its location.He indicated that it may have been disposed of by emergency services or the hospital.Should additional information become available, a supplemental record will be filed.(b)(4).

Event Description

The maintenance director of a nursing facility reported that one of the facility's patients was walking through the hallway, where they allegedly walked into the rpl600-1 lift, and one of the hooks on the lift's hanger bar went through the patient's mouth area.Emergency services was called, and they transported the patient to the hospital.The patient remained in the hospital for at least 3 days; however, the specific injuries sustained are unknown.

• Brand Name: INVACARE RELIANT 600 HEAVY-DUTY POWER LIFT WITH MANUAL LOW BASE
• Type of Device: LIFT, PATIENT, 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: 7280538
• MDR Text Key: 100399491
• Report Number: 9616091-2018-00005
• Device Sequence Number: 1
• Product Code: FNG
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: RPL600-1
• Device Catalogue Number: RPL600-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization