MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA OXYLOG 2000; VENTILATORS, TRANSPORT

Catalog Number 8413950

Device Problems Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 the device alarmed for an internal device failure.In such a case a sufficient ventilation function is no longer available.There were no patient consequences reported.

Manufacturer Narrative

The affected device was examined on site by dräger service technician and information was provided for further investigation at the manufacturer¿s site.Based on the investigation it was not possible to finally clarify whether or not the event happened during use on the patient although there was no indication found for a failure during use on a patient.It had been reported that the error message "17 00 00 00 00 ventilator inop" was posted as constant alarm during charging the device at the date of event.The error message "17 00 00 00 00 ventilator inop" indicates that the mv valve is blocked.In case of the technical problem (¿ventilator inop¿) the device alarms visually and acoustically, and the ventilation stops.In this case an alternative independent ventilation device has to be used instantly, as described in the instructions for use.There were no patient health consequences reported.The affected device was manufactured in march 2004 and considered as "end of life".The device was scrapped onsite and not available for further investigation.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

It was reported that the device alarmed for an internal device failure.In such a case a sufficient ventilation function is no longer available.There were no patient consequences reported.

• Brand Name: OXYLOG 2000
• Type of Device: VENTILATORS, TRANSPORT
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11573700
• MDR Text Key: 243741184
• Report Number: 9611500-2021-00129
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K943531
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8413950
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.