Complaint form received via (b)(4) tech support on behalf distributor in the (b)(4) details an event which occurred at a user facility: event details the third party distributor in the (b)(4), reported "a problem with part number 11744-850k batch number (b)(4), it appears that it is not a complete set and that certain parts are not molded on as they should be." the end user is [redacted].It was afterwards revealed that the alleged problem was discovered by the sales manager [redacted] when she went to do some training at the hospital on the (b)(6).It was also reported by [redacted]: "because they (the hospital staff) have not had any training & are not experienced with oscillation they did not know to look for leaks in the system when the oscillator does not achieve pressures of 39-42 during set up & calibration.Once i had found the set i was using to be faulty i looked at the rest of their stock & found the tubing to be loose in the packet instead of attached where it should be." it was also reported by sales manager, that the faulty product from batch (b)(4) "was not used on a patient - however in the last few weeks they (the hospital staff) have sent all of their machines to [redacted] with the same problem (not reaching pressure) - [redacted] have been unable to find faults with the machines so it may be that some have been used on patients whilst faulty." the hospital will return the faulty products and sales manager has planned to send replacements.
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