Model Number 4000 |
Device Problems
Degraded (1153); Device Sensing Problem (2917)
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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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T was reported that pump exhibited failure not recognized message and there was damage noted.No patient injury was reported.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No information has been provided to date.
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Manufacturer Narrative
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B5: additional information received on 01-aug-2022 via email and attached to complaint object: this pump was not being used on a patient.Initial reporter name, email, and phone number have been updated.H6: event problem and evaluation codes: updates not required., corrected data: d4: correction: model number: 4000.
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Manufacturer Narrative
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H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The reported problem was not related to any previous repair.Visual inspection found the top case was chipped in the front and the right plunger case broken.There was evidence of the reported problem in the event history log.The reported problem was seen upon inspection as the chip was broken off the plunger printed circuit board and the case damaged.This was due to impact and attributed to improper handling by the customer.For corrective action the plunger pcb and case were both replaced.A manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.
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Search Alerts/Recalls
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