Catalog Number 44191609 |
Device Problem
Device Fell (4014)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd ds headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Serial creation date: unknown.
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Event Description
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It was reported that bd max¿ instrument door closed too quickly and bruised the customers hand.The following information was provided by the initial reporter: the customer announced that the door closes too quickly.No more resistance when closing, gravity lets the door close quickly.Probably the suspension / hydraulics are defective.The customer bruised his hand.The swelling has already subsided.
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Manufacturer Narrative
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H.6.Investigation: the complaint of "door won't stay open" was reported against the bd max refurbished instrument catalog number 44191609, serial number (b)(6).The customer reported that the instrument door closes too quickly.The door would close without any resistance and would fall shut.The customer received injury on hand from the issue.Field service was dispatched.Field service determined that the gas spring cylinder came loose, disconnecting the gas cylinder from the door.Field service reconnected the gas cylinder and applied loctite.No parts were replaced for this case.Root cause is determined to be that the gas cylinder came unscrewed from the socket.The complaint is confirmed as an instrument issue.The investigation consisted of a review of the instrument installation, and service history, and related complaint data.No new risks, trends, or hazards were identified.Bd will continually monitor for trend.
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Event Description
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It was reported that bd max¿ instrument door closed too quickly and bruised the customers hand.The following information was provided by the initial reporter: the customer announced that the door closes too quickly.No more resistance when closing, gravity lets the door close quickly.Probably the suspension / hydraulics are defective.The customer bruised his hand.The swelling has already subsided.
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Search Alerts/Recalls
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