MAUDE Adverse Event Report: MERCURY MEDICAL; NONE

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Reference uf report# (b)(4).

Manufacturer Narrative

Mercury medical qa received a mdr product problem report on (b)(4) 2013 and the identified neo-tee (t-piece resuscitator) device catalogue# 10-50801 on (b)(4) 2013.A complaint was logged as (b)(4).As this was not a direct sale, additional information was obtained through a dealer's sales representative.The user discarded the labeling that identified the batch number which remains unknown.The device, as reported by the dealer's sales representative, reportedly had been used on the same patient multiple times and as long as two months without flow interruption.As found, the device had dried fluids inside the patient valve/peep cylinder.The controller was set between low/medium pip pressure and the peep was 1/2 turn from max.All connections were secure.The cap and strap was disengaged and the corrupted oxygen tubing connector showed some crazing from over-compression onto the o2 input nipple.The controller was shaken to expose loose components/particulates and the inside was examined under 10x magnification for particle contaminants but no loose components or particulates were detected.On (b)(4) 2013, qe performed functional test on the returned unit as described in the dfu, pre-use check section.The device in its "as found" condition was connected to a flowmeter set to 10 lpm air flow.The resulting peep reading was 5.0 cm h20 on the manometer.When the peep hole was covered, the manometer indicated a positive inspiratory pressure (pip) of 20 cm h20 which is normal.No flow interruption was observed during 10 minutes of operation time.After additional tests, where the controller and peep valve settings were adjusted through the full range of pip and peep, the device demonstrated normal operation, within expected ranges and no flow interruption was observed.A root cause for the reported flow interruption could not be determined.The calculated rate for functional neo-tee defects, which includes ncrs and complaints over the previous two years, is low and acceptable.Patient risk for the reported defect was assessed as low risk via fmea, and was reviewed and accepted by a medical professional.Conclusion: device tested functional and readings fell within the specifications listed in the dfu.A root cause for the reported interruption of flow could not be determined as the returned device operated normally, within specification.

• Type of Device: NONE
• Manufacturer (Section D): MERCURY MEDICAL; 11300 49th st. north; clearwater FL 33762 480
• Manufacturer Contact: brian morrison, manager ; 11300 49th st. north; clearwater, FL 33762 ; 7275730088
• MDR Report Key: 3646533
• MDR Text Key: 4195281
• Report Number: 1024404-2013-00003
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• PMA/PMN Number: K093913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Remedial Action: Inspection
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 12/11/2013
• Initial Date FDA Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1