MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA OXYLOG 3000PLUS; VENTILATORS, TRANSPORT

Catalog Number 5704811

Device Problem Loss of Power (1475)

Patient Problems Urinary Retention (2119); No Consequences Or Impact To Patient (2199); Low Oxygen Saturation (2477)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user facility report stated: "the oxylog was put into regular operation before the patient arrived.The device was used for the transport from the shock room to the ct and in the ct.In ct, the o2 supply was switched from bottle to central supply.After the patient was transferred to the ct, the device was connected to the power supply (green socket).Before the anesthesia personnel left the ct into the control room ct, the monitor was positioned so that it can be viewed from the control room and the oxylog device was checked for proper function.In the course of the short examination a decrease of oxygen saturation and heart rate could be observed.The anesthesia personnel entered the examination room and found that the oxylog appeared to be switched off.After restarting the device, it worked perfectly.It started in pre-programmed ippv mode and had to be switched to previously used bipap mode.We're assuming the patient didn't suffer any damage.".

Manufacturer Narrative

The affected oxylog 3000plus was available for the investigation.When the device arrived, the battery had a charge of 88% and the last service was in october 2018.For analysis, a 4-day continuous run was performed with the device, in which no deviation or malfunction was found.An analysis of the logbook was not possible because it was deleted at 8:33 am on the day after the event ((b)(6) 2019).Based on the investigation results, the described incident could not be confirmed and no root cause could be identified.In the case of a technical fault, the device alarms visually and acoustically, in case of power failure only acoustically.In the event that the device no longer provides sufficient ventilation, the instructions for use state that an alternative ventilation option must be kept available.

Event Description

Please refer to the initial-report.

• Brand Name: OXYLOG 3000PLUS
• Type of Device: VENTILATORS, TRANSPORT
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8498671
• MDR Text Key: 145122564
• Report Number: 9611500-2019-00114
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• 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: 5704811
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1