MAUDE Adverse Event Report: INVACARE TAYLOR ST PATIENT TRANS; SLING

Model Number NA:PATIENTTRANS

Device Problem Material Separation (1562)

Patient Problem Death (1802)

Event Date 07/15/2015

Event Type  Death  

Manufacturer Narrative

Invacare's lawyer spoke with the patient's lawyer who stated the lift was identified as a hill-rom lift, the sling is reported to be an invacare device.The lawyer reported the sling ripped.Although in the documents the use of one caregiver instead of two is repeatedly identified as the cause of the incident.The model, age and manufacture of the sling is not available.The device was not returned and no return is expected.Based on available information the underlying cause could not be determined.If more information is received, the decision will be reevaluated.The user manual 1023891 rev-i page 5 states: invacare slings are made specifically for use with invacare lifts.For the safety of the patient, do not intermix slings and lifts of different manufacturers.

Event Description

Lawsuit received stating patient was being transferred with an unspecified patient lift when the patient fell and sustained a broken rib and other internal injuries which lead to the patient bleeding to death.No malfunction of the lift is reported.

• Brand Name: PATIENT TRANS
• Type of Device: SLING
• Manufacturer (Section D): INVACARE TAYLOR ST; 1200 taylor st; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6654305
• MDR Text Key: 78016572
• Report Number: 1531186-2017-00010
• Device Sequence Number: 1
• Product Code: INE
• 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: Other
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NA:PATIENTTRANS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• 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 Outcome(s): Death