FDA.reportPublic FDA data

MAUDE MDR 5265138

MDR report key
5265138
Report number
9680866-2015-00108
Event key
0
Event type
3
Date of event
2015-11-18
Date received
2015-12-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JEANETTE JOHNSON
Address
7900 TRIAD CENTER DRIVE SUITE 400 GREENSBORO NC 27409 US
Phone
336-336-3365
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADULT HIGH CONCENTRATION REBREATHER , OXYGEN MASKMASK, OXYGEN, NON-REBREATHINGUNOMEDICAL S.A. DE C.V.KGB104-E105996R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-030

Event Narratives#

N

Patient 1

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. EXPIRATION DATE: 08/2019. DEVICE MANUFACTURE DATE: 08/2014. (B)(4).

D

Patient 1

IT WAS REPORTED THAT THE OXYGEN TUBING DISCONNECTED FROM THE MASK'S CONNECTOR WHILE IN USE ON THE PATIENT. THERE WAS NO ADVERSE IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

N

Patient 1

ADDITIONAL INFORMATION: A QUALITY INVESTIGATION WAS CONDUCTED TO INCLUDE A BATCH REVIEW AND TESTING OF RETENTION SAMPLES OF 104-E AND NO DISCREPANCIES WERE NOTED. A PRIOR CAPA WAS LEVERAGED FOR THIS COMPLAINT AND HAS CONCLUDED THAT POSSIBLE ROOT CAUSES FOR DISCONNECTION COULD BE ATTRIBUTED TO POOR APPLICATION OF SOLVENT THAT JOIN THE TUBE TO MASK CONNECTOR AND THE INCONSISTENCY OF MANUFACTURING OPERATORS TO FOLLOW ASSEMBLY WORK INSTRUCTIONS. CORRECTIVE ACTION HAS BEEN IMPLEMENTED. THIS COMPLAINT WILL BE CLOSED WITHOUT FURTHER ACTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).