MAUDE Adverse Event Report: AESCULAP AG AIR HOSE 5.0M AESC.-DRAEGER/AESC.LARGE; HIGH SPEED POWER SYSTEMS

Model Number GA466R

Device Problem Burst Container or Vessel (1074)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Country of complaint: (b)(6).Original medwatch report (2916714-2016-00936) submitted for this incident on (b)(6).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.Country of complaint: (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.

• Brand Name: AIR HOSE 5.0M AESC.-DRAEGER/AESC.LARGE
• Type of Device: HIGH SPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 6955231
• MDR Text Key: 89833133
• Report Number: 9610612-2017-00515
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA466R
• Device Catalogue Number: GA466R
• Device Lot Number: 51977098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Distributor Facility Aware Date: 10/25/2016
• Device Age: 4 YR
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR