CONSOLIDATED MEDICAL EQUIPMENT COMPANY CGA, SUREFIT GROUND PAD WITH 10FT CABEL, 100/CASE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number 410-2000 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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The customer reported that the device, 410-2000, cga, surefit ground pad was being used on an unknown date during an unknown procedure and ¿the pad will not remain in contact with the patient's skin.Staff complains it is lifting off the skin and losing contact¿.This has happened multiple times.There was no impact or injury to the patient.There was no report of medical/surgical intervention or prolonged hospitalization.After further assessment it was found that the reporter ¿did not receive the specifics from the or.It was a generic statement that the pads were not sticking and were lifting off the skin.I was not made aware of any patient or staff injury related to these incidents¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Event Description
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The customer reported that the device, 410-2000, cga, surefit ground pad was being used on an unknown date during an unknown procedure and ¿the pad will not remain in contact with the patient's skin.Staff complains it is lifting off the skin and losing contact¿.This has happened multiple times.There was no impact or injury to the patient.There was no report of medical/surgical intervention or prolonged hospitalization.After further assessment it was found that the reporter ¿did not receive the specifics from the or.It was a generic statement that the pads were not sticking and were lifting off the skin.I was not made aware of any patient or staff injury related to these incidents.¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 56 reports, regarding 505 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: prepare the skin at the application site according to facility protocol.If no protocol exists, clip excess hair at application site, clean and disinfect area to remove oils, lotions, etc., and allow to dry thoroughly.Do not open package until ready to apply pad to skin.Inspect the pad and cable.Do not use if product is expired or apparently damaged.Check expiration date on package.This issue will continue to be monitored through the complaint system to assure patient safety.
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Search Alerts/Recalls
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