MAUDE Adverse Event Report: MAXTEC, LLC MAXBLEND; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number R204P05-001

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

Blender delivered 21% with dial set at 100% fio2.Incident occurred during infant delivery/resuscitation.There was no injury to the patient.Saturation improved after oxygen was delivered.
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manufacturer response for air/o2 blender, maxblend high-flow (per site reporter).
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maxtec will obtain product complaint that has been filed and has obtained unit for testing.Maxtec will also involve carefusion as the actual manufacturer.

• Brand Name: MAXBLEND
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): MAXTEC, LLC; 6526 south cottonwood street; 300 west; salt lake city UT 84107
• MDR Report Key: 3840273
• MDR Text Key: 4660648
• Report Number: 3840273
• Device Sequence Number: 1
• Product Code: CCL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: R204P05-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1