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

Catalog Number 5704811

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Injury (2348); No Patient Involvement (2645)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The device was designated for a patient transport in the hospital.During carrying the device, the handle became loose because both screw fastenings became loose.The device dropped down at the foot of a staff member.Staff member was medically treated.No patient injury reported.

Manufacturer Narrative

The affected handle and one of the two fastening screws were available for the examination.In the optical analysis, the remains of loctite were visible on the screw.The threads on both sides of the handle were partially torn out.Based on the available information, it was not possible to determine what caused the handle to come loose.The handle screws are tightened to a specified torque and secured with loctite according to the manufacturer's specifications.A slow loosening of the screws is recognizable during the equipment examination before use.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

Pease see 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: 8690715
• MDR Text Key: 147890876
• Report Number: 9611500-2019-00176
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)181012(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

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• 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: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other