Catalog Number 1613 |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The sample was not returned; however, the customer provided a photo for evaluation.A visual exam was performed and it was observed there was a type of cut in the tubing.No other issues were observed.The device history record of batch number 74a1901330 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.The complaint is confirmed based on the photo, however, the actual sample is needed to conduct a proper investigation and to determine a root cause.If the sample is returned, a follow-up report will be submitted with investigation results.
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Event Description
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The complaint is reported as: "crack found in circuit prior to set-up during leak test.Clinician kept the circuit and will send back for investigation.No further information was provided." no patient harm or injury reported.
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Event Description
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The complaint is reported as: "crack found in circuit prior to set-up during leak test.Clinician kept the circuit and will send back for investigation.No further information was provided." no patient harm or injury reported.
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Manufacturer Narrative
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Qn#(b)(4).One (1) 1613 ventilator tubing set,long length was received for investigation.Upon receipt the tube set was visually inspected for any signs of abuse/misuse/damage.The complaint defect was pointed out with black marker.The defect is a "cut", or "slit" that runs approximately a 1/2 inch long parallel to one of the tube ridges.The complaint has been confirmed.However, a definitive root cause cannot be determined.The cut could have been the result of a box cutter when opening the shipping packaging/box.Or, the tubing could have come into contact with a sharp object in the clinical setting.The source of the cut cannot be confirmed.
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Search Alerts/Recalls
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