MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB COMPRESSOR MINI; GAS-MACHINE, ANESTHESIA

Catalog Number 6481779

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2017

Event Type  malfunction  

Event Description

It was reported that the compressor failed to turn on.There was no patient involvement reported.(b)(4).

Manufacturer Narrative

The compressor was investigated by our field service engineer.He found that the compressor had blown fuses.The fuses and mains inlet were replaced.The compressor was returned to service after successful function and safety checks/tests.Ocular inspection of the returned parts found the mains inlet dusty and the fuse holder was defective due to heat exposure.Earlier investigations have determined that the cause of a blown fuse could be one or a combination of the following causes: electrical transients (voltage and/or current spikes) in the mains power.Bad electrical connection between the fuse and the fuse holder, e.G.Due to vibrations in the system.Chemicals used from cleaning the device (by spraying) causing corrosion and as second effect bad connection.Dust in the environment if deposited on the fuse holder, which will insulate and increase the temperature around the fuse and affect the contact between fuse and fuse holder.According to the user's manual, a preventive maintenance shall be performed after 5000 operating hours.It includes visual inspection of damage of parts and preventive cleaning of dust in the main inlet.If the mains inlet is broken, the compressor will not start.If the failure occurs with a ventilator connected to the compressor, the supply of air stops and an alarm will activate.Our conclusion is, that the compressor mini did not start due to a blown fuse.

Event Description

(b)(4).

• Brand Name: COMPRESSOR MINI
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 6310467
• MDR Text Key: 67218789
• Report Number: 8010042-2017-00049
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K023354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6481779
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1