* R129P02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-15 for * R129P02 manufactured by Maxtec.

Event Text Entries

[2959415] Upon inspecting the transport incubator for the neonatal transportation aircraft, our clinical engineer discovered a factory defect on the dual oxygen/air hose. The oxygen (o2) and air connections were reversed on the o2/air hose where it connects to the ventilator. The hose was in use in the fall of 2012. Due to the design of the ventilator on this transport incubator, there were no o2 sensors that would have alerted the flight nurse that the o2 and air sources were inverted. O2 percentage is determined via a mechanical blender. With the defective hose, o2 concentrations delivered to the patient are not accurate compared to the blender settings. This defective hose is only in use when the incubator is hooked into a hospital's o2/air system via wall outlets, or when hooked into a helicopter or airplane via wall outlets. It is not used during transport when using the tanks on the stretcher/incubator. During the time period that the hose was in service there were 9 confirmed patients that were transported in this incubator plus two additional that may have been transported in this incubator. An examination by our flight nurse team and risk management showed no adverse effect on the patients transported during this time. ======================manufacturer response (per site reporter). ======================the manufacture is conducting their own internal investigation to determine possible root cause. In addition they are proactively notifying other customers that may have possibly been affected.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2852555
MDR Report Key2852555
Date Received2012-11-15
Date of Report2012-11-15
Date of Event2012-11-07
Report Date2012-11-15
Date Reported to FDA2012-11-15
Date Added to Maude2012-11-30
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameSET, TUBING
Product CodeCCL
Date Received2012-11-15
Model NumberR129P02
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age*
Device Sequence No1
Device Event Key0
ManufacturerMAXTEC
Manufacturer Address6526 SOUTH COTTONWOOD STREET 300 WEST SALT LAKE CITY UT 84107 US 84107


Patients

Patient NumberTreatmentOutcomeDate
10 2012-11-15

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