MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-07 for AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL GA513R manufactured by Aesculap Ag.
[129745252]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[129745253]
It was reported by the healthcare professional "during a cervical surgical procedure there was a loud explosion sound and the pressure from the broken piece of the air hose hit the nurse and cause the nurse to have chest pains and difficulty breathing. Immediately follow the incident the nurse was examined and had an x-ray showing no fracture to the chest. On (b)(6) 2018 still feeling tightness of the chest and not breathing smoothly the nurse was seen by a doctor in the department of thoracic medicine and released to go back to work. Before the explosion, the hose was complete without any missing parts. The broken piece was found in front of the nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00523 |
| MDR Report Key | 8144125 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-07 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-11-05 |
| Date Facility Aware | 2019-01-21 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2015-07-08 |
| Date Added to Maude | 2018-12-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 Phone | 3145515988 |
| 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 3.0M AESC.-DRAEGER/AESC.SMALL |
| Generic Name | HIGH SPEED POWER SYSTEMS |
| Product Code | GET |
| Date Received | 2018-12-07 |
| Returned To Mfg | 2018-11-14 |
| Model Number | GA513R |
| Catalog Number | GA513R |
| Lot Number | 52138342 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 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. Required No Informationntervention | 2018-12-07 |