MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ALDUK IV; REGULATORS, HIGH-PRESSURE GAS

Catalog Number 5790093

Device Problems Overheating of Device (1437); Gas/Air Leak (2946)

Patient Problem Burn(s) (1757)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that when after attaching a full o2 cylinder to a pressure reducer and opening the valve, the connection was immediately leaking (loud hissing noise) and the pressure reducer immediately became hot.The cylinder valve was closed again.The user suffered a blister at the hand.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The affected alduk iv was provided for the investigation.In a visual inspection, it was found that the bottle connection is sooty.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 federal institute for materials research and testing) 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 din 477-1 in the version for the german 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.

• Brand Name: ALDUK IV
• Type of Device: REGULATORS, HIGH-PRESSURE GAS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8806180
• MDR Text Key: 151655048
• Report Number: 9611500-2019-00214
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K103625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 5790093
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1