Model Number 104232 |
Device Problems
Fluid/Blood Leak (1250); Mechanical Problem (1384); Moisture Damage (1405)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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It was reported that the patient complained of a hole in their shower bag.The shower bag was not returned to the distributor, and the actual hole was not confirmed.Additional information received on 01oct2020 reported that the patient noticed water inside of their shower bag during their shower.The bag was disposed of.
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Manufacturer Narrative
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This event occurred at (b)(6) hospital in (b)(6).Section h6: additional information.Section h8: correction.Manufacturer's investigation conclusion: the report of a hole in the patient¿s shower bag could not be confirmed as no product or photos of the damage were received for evaluation.The patient reportedly noticed a hole in their shower bag after noticing water in the bag during a shower on (b)(6) 2020.The gogear shower bag was discarded.No adverse patient consequences were reported in association with the event.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) and patient handbook state that the wear and carry accessories should be inspected periodically during use.If there are any issues the item should not be used, and a replacement should be requested.These documents provide instructions for showering with the use of the shower bag.The relevant sections of the device history records for the gogear shower bag were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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