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

Catalog Number 5704811

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation was started.A follow-up report will be sent as soon as the results are available.

Event Description

It was reported that a transport ventilator oxylog 3000plus switched off whilst in the corridor back from ct scan.Patient 3 minutes away from the unit.Doctor on transfer identified situation immediately, manual ventilation commenced immediately, patient brought back to the unit safely.No injury reported.

Event Description

Please see initial report.

Manufacturer Narrative

The affected device was provided for the investigation.Based on the log entries the date of event was likely (b)(6) 2019, as the device was not in use on (b)(6) 2019 as initially reported.On (b)(6) the device was switched on and put into operation at 12:44.After around one hour the operation mode of the device was switched from central oxygen to cylinder and from mains power to battery.About two minutes later, at 13:43, the alarms ¿paw measurement inop¿ and ¿device failure¿ alarms were generated visually and audibly by the device.The logged error codes indicate that the internal supply voltage of the sensors was out of range, and as a result two sensor failures were detected.During our analysis the device check was passed.However, when opening the device it was found that a standoff in the electronics compartment was broken off.No additional failure was found.The standoff has an aluminum coating (conductive surface) and possibly made a temporary connection on the pcb which led to the reported problem.The root cause for the damaged standoff is likely external mechanical stress beyond the specified limits.Oxylog devices are compliant with the relevant standards including resistance to mechanical stress caused by dropping.Drop tests are part of the standards iso 10651-3:1997 and iec 60601-1:2012 in conjunction with iec 60601-1-12:2014.In case of a malfunction of the internal sensors, the device stops the ventilation and generates a visual and audible alarm.The ifu states that an alternative independent ventilation device has to be used instantly in this case.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 8706577
• MDR Text Key: 148290170
• Report Number: 9611500-2019-00178
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)171116(17)200904(93)5704811-22
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1