AIR HOSE 5.0M AESC.-DRAEGER/AESC.LARGE GA466R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-17 for AIR HOSE 5.0M AESC.-DRAEGER/AESC.LARGE GA466R manufactured by Aesculap Ag.

Event Text Entries

[89833035] The investigation was carried out by the aesculap technical service department (ats). It has been ascertained, that the reported product was manufactured in 2013 and is an old version of the hose. This version of the hose was prone to flaws which could lead to a burst. Therefore this hose was changed. Batch history review: the device history files have been checked for the available lot number and found to be according to the specification, valid at the time of production. Conclusion and root cause: this failure occurred most likely due to design error. Corrective action: a change was initiated to eliminate the failure. This version of the hose has not been marketed since 2015.
Patient Sequence No: 1, Text Type: N, H10


[89833036] (b)(6). Original medwatch report (2916714-2016-00936) submitted for this incident on 10/27/16. Additional medwatch reports are being submitted to record injury of total of 5 people related to the reported incident. This includes: 9610612-2017-00512, 9610612-2017-00513, 9610612-2017-00514, 9610612-2017-00515. (b)(6). It was reported that 5 people from the operation team were injured when the air hose burst. Minimal information was able to be obtained related to the injuries or treatment(s) however, it was reported that there was no permanent damage to any effected individual.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2017-00512
MDR Report Key6955227
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-10-17
Date of Report2017-10-17
Date Facility Aware2016-10-25
Date Mfgr Received2016-07-07
Device Manufacturer Date2013-10-28
Date Added to Maude2017-10-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIR HOSE 5.0M AESC.-DRAEGER/AESC.LARGE
Generic NameHIGH SPEED POWER SYSTEMS
Product CodeBYX
Date Received2017-10-17
Returned To Mfg2017-07-11
Model NumberGA466R
Catalog NumberGA466R
Lot Number51977098
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age4 YR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-10-17

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