MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for ALDUK IV 5790093 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[138936693]
The affected alduk iv was provided for the investigation. In a visual inspection, it was found that the bottle connection is sooty. No further damage could be detected. After replacing the o-ring in the bottle connection, a functional test was performed in which no deviation could be detected. There is no indication of a device malfunction. The alduk iv passed the normative test for resistance to internal flammability when exposed to oxygen pressure surges (test according to (b)(6)) and is approved in accordance with iso 10524-1: 2006. The dimension and size of the alduk bottle connection are according to the valid standard (b)(4) in the version for the (b)(6) market. The connection is safe when handled correctly. In case the alduk iv is connected to the gas cylinder without gas pressure, the cylinder connection may become loose. The instructions for use include the warning that the valve should always be opened slowly so that such leaks are noted. In addition, it warns that the cylinder connection must be checked for tightness before each opening of the cylinder valve. If this does not happen and the gas escapes through leakage, there is a possibility that the alduk will heat up due to heat generated by the gas flow and burn the connection seal.
Patient Sequence No: 1, Text Type: N, H10
[138936694]
It was reported that an alduk 4 became hot during use, the seal charred and a flash was seen. According to the user, the bottle was changed correctly and properly connected by hand. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2019-00083 |
| MDR Report Key | 8420171 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-02-12 |
| Device Manufacturer Date | 2018-06-30 |
| Date Added to Maude | 2019-03-14 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SONJA HILLMER |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | L 23542 |
| Manufacturer Country | GM |
| Manufacturer Postal | 23542 |
| Manufacturer Phone | 4518822868 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALDUK IV |
| Generic Name | REGULATORS, HIGH-PRESSURE GAS |
| Product Code | CAN |
| Date Received | 2019-03-14 |
| Model Number | NA |
| Catalog Number | 5790093 |
| Lot Number | NA |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR?GERWERK AG & CO. KGAA |
| Manufacturer Address | MOISLINGER ALLEE 53-55 L?BECK 23542 GM 23542 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-14 |