MAUDE Adverse Event Report: H FINE & SON LTD INVACARE COMFORT SLING, LARGE; LIFT, PATIENT, NON-AC-POWERED

Model Number 2485970

Device Problems Material Separation (1562); Device Fell (4014)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 08/14/2021

Event Type  Injury  

Manufacturer Narrative

The facility was contacted for additional information about the event.They advised that they use the same lifts and slings on different patients, and they were unable to provide the specific model of the lift or sling being used at the time of this event.They indicated that it was a 450-pound lift, which was used on all different patients weighing up to 450 pounds.The facility advised that they inspect the slings before they are used on each patient.The slings are washed in lukewarm water with no bleach and are dried on medium heat.A photograph of the sling was provided, which shows that one of the loops has detached on one side from where it was sewn to the strap.The tag is missing from the sling, so the model and lot number cannot be verified.However, it appears to be consistent with an invacare comfort sling, size large, which has a weight capacity of 500 pounds.The patient slings owner¿s operator and maintenance manual advises, "laundering should always be done with dark colors.The sling should be washed regularly in a water temperature not to exceed 180°f (82°c).Do not bleach.Air dry or dry at low temperature.Inspect with each use.Refer to tagged washing instructions on the sling.After each laundering (in accordance with instructions on the sling), inspect sling(s) for wear, tears, and loose stitching.Bleached, torn, cut, frayed, or broken slings are unsafe and could result in injury.Discard immediately." though the identity of the sling is still unconfirmed, because the photograph does not rule it out as an invacare sling, an mdr is being filed for this event.The facility has been asked to return the sling to invacare for further evaluation, but they have indicated that they are not aware of its current location, and it may not be available to be returned.Should additional information become available, a supplemental record will be filed.

Event Description

A patient reported that she resides in a facility, and two aides were using a lift to transfer her from her power chair to her bed when the sling broke causing her to fall back hard into the chair, which hurt her back.She was transported to the hospital where they performed x-rays and a ct scan, she was given a pain pill and antibiotic, and a catheter was inserted where she was bleeding internally.She was at the hospital for 10 hours and then released back to the facility.The patient advised that the x-rays and ct scan taken at the hospital were clear, but when she went to a follow-up visit with the doctor 10 days later, they said she had a fractured rib for which there is no treatment.The doctor advised that it would heal on its own but will cause pain, so they gave her naproxen and a pain patch.

• Brand Name: INVACARE COMFORT SLING, LARGE
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): H FINE & SON LTD; everstrong bag manufactory; hou jie da jing; dongguan, dongguan ; CH
• MDR Report Key: 12548736
• MDR Text Key: 274008186
• Report Number: 1531186-2021-00004
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/29/2021,09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2485970
• Device Catalogue Number: 2485970
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Distributor Facility Aware Date: 09/21/2021
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 168