MAUDE Adverse Event Report: MAXTEC LLC. MAXBLEND LOW FLO; MIXER, BREATHING GASES, O2 BLENDER

Device Problems Gas Output Problem (1266); Kinked (1339); Device Slipped (1584); Material Twisted/Bent (2981)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/15/2017

Event Type  malfunction  

Event Description

Respiratory was called to attend high risk delivery.Upon delivery, the newborn required positive pressure ventilation (ppv)and the pediatrician requested 100% fio2.The o2 blender failed to provide increased fio2 above 21%.Both oxygen and air tanks were full and all connections were secure properly.Failure to provide adequate oxygen needs resulted in a neonatal priority being called on the patient.Patient was transferred to special care nursery (scn), another oxygen blender was brought in, and 100% fio2 was provided with continued ppv.The newborn's oxygen saturations immediately responded and ppv was discontinued.The o2 blender was pulled from service and inspected by biomed.Upon inspection, biomed determined that one of the fittings was loose which allowed the tubing to twist and become kinked.This affected the delivery of the fio2 to the patient.This was unable to be identified at the time of usage because the kink was covered by a protective sheath.Biomed tightened the fitting so hose can be properly tightened to prevent twisting.This removed the kink from the hose.

• Brand Name: MAXBLEND LOW FLO
• Type of Device: MIXER, BREATHING GASES, O2 BLENDER
• Manufacturer (Section D): MAXTEC LLC.; 2305 south 1070 west; salt lake city UT 84119
• MDR Report Key: 6893367
• MDR Text Key: 87350446
• Report Number: 6893367
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2017
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1