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Model Number 6556L |
Device Problem
Device Slipped (1584)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer contacted us via phone call.Mercy is saying that they have product that looks to be a different color and the material feels different, the teeth are not grabbing the material allowing the belt to slip through the buckle.The date the issue was discovered is unknown and no patient incident or injury was reported.
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Manufacturer Narrative
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Product is expected to be returned for evaluation but has not been received in by the manufacturer.Therefore this report is based solely on the customer reported issue.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The instructions for use state: during the application of the belt the strap should lay flat across the buckle.Tuck excess under the belt.Always verify proper closure before use.Always check for skin integrity, proper circulation and range of motion when the belt is in use.Ensure that the belt is secure and does not compromise the patient¿s medical condition and does not interfere with tubes, lines or other equipment.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file (b)(4).
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Manufacturer Narrative
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H3 evaluation summary: visual findings observed 38 gait belts received - this product is sold per case, and each case consists of 50 gait belts.For that reason, the quantity received is equivalent to 1 case.3 of the belts received were already opened; the rest were still in their original packaging.No abnormalities were observed.Evaluation found the webbing exhibited slippage or the buckle teeth was not securing the webbing if the webbing was not slipped through the buckle all the way.Using the ifu application, the webbing did not exhibit any slippage.There were several complaints received for straps slipping which were determined to be due to manufacturing issues that have been addressed via the capa system.A review of the device history record did not show any nonconformities and the device passed all product verification testing and met specifications when shipped.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The instructions for use state: during the application of the belt the strap should lay flat across the buckle.Tuck excess under the belt.Always verify proper closure before use.Always check for skin integrity, proper circulation and range of motion when the belt is in use.Ensure that the belt is secure and does not compromise the patient¿s medical condition and does not interfere with tubes, lines or other equipment.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file: (b)(4).
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Event Description
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Supplemental medwatch being sent for additional information.
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Search Alerts/Recalls
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