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

Catalog Number 5790093

Device Problems Use of Incorrect Control/Treatment Settings (1126); Overheating of Device (1437); Unexpected Therapeutic Results (1631); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

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 at the beginning of the device self-test on an oxylog3000 the user opened the o2 supply bottle.Immediately afterwards, a flash was seen at the transition of the o2 supply bottle to the alduk pressure reducer.There were no patient nor user consequences reported.

Manufacturer Narrative

The affected device was available for the investigation; further available information was also considered in the course of the investigation.Based on the investigation the reported event could be confirmed.The affected gas cylinder connection of the alduk iv showed traces of soot and the remains of the o-ring, indicating that heat had occurred on the device.The o-ring was replaced on the affected device and the device was tested on an o2 cylinder without any error pattern.There is no device fault and the alduk iv is ready for use again.If the cylinder connection is not completely tightened before opening the valve and the gas escapes through a leak, heat may be generated, and the o-ring may be thermally damaged.Therefore, a use error must be assumed.The operating instructions of the device contain a corresponding warning and remedial measures.All alduk series have passed the normative test for resistance to burnout when exposed to oxygen pressure surges ("bam test") and are approved according to iso 10524-1:2006.The dimensions and sizes of the alduk cylinder connection in the version for the german market comply with the applicable standard din 477-1.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

Please refer to the initial-report.

• 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: 10366988
• MDR Text Key: 202782399
• Report Number: 9611500-2020-00271
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• PMA/PMN Number: -
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5790093
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1