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.
[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
| Report Number | 9610612-2017-00512 |
| MDR Report Key | 6955227 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-17 |
| Date Facility Aware | 2016-10-25 |
| Date Mfgr Received | 2016-07-07 |
| Device Manufacturer Date | 2013-10-28 |
| Date Added to Maude | 2017-10-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR HOSE 5.0M AESC.-DRAEGER/AESC.LARGE |
| Generic Name | HIGH SPEED POWER SYSTEMS |
| Product Code | BYX |
| Date Received | 2017-10-17 |
| Returned To Mfg | 2017-07-11 |
| Model Number | GA466R |
| Catalog Number | GA466R |
| Lot Number | 51977098 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-17 |