The affected resuscitator was not received for investigation,neither was a picture provided.Lot no.Was not provided and investigation could therefore not be made on retention sample, neither could production records be review.Contacted customer several times to obtain more information about the incident, customer is not responding.Due to limited information, it is difficult to verify the reported failure and the root cause of the reported failure cannot be identified.Customer has stated that patient condition was affected, but we has not been possible to obtain information on how patient was affected.Spur ii resuscitator is designed for use by cpr-trained paramedics, and information for safety provided in accompanying document (ifu) inform that the resuscitator must be unpacked and prepared for immediate use before it is placed ready for use in emergency situation.The integrity of kits issued for storage ready for use should be inspected at regular intervals.Caution has been given to alert the user to switch to mouth-to-mouth resuscitation if efficient ventilation cannot be obtain with the device.It is evaluated, that if the user had adhered to the instructions provided the device would not have been assumed to be ready for use.
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