MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB COMPRESSOR MINI; COMPRESSOR, AIR, PORTABLE

Catalog Number	6481787
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A follow-up medwatch will be submitted when additional information becomes available.
Event or Problem Description
It was reported that the compressor often switched to standby during use.There was no patient harm.(b)(4).
Additional Manufacturer Narrative
The investigation of the compressor switching into standby has been completed.According to the problem description, the compressor would switch to standby mode very often during running mode.When the compressor switch to standby mode, the unit will stop to deliver compressed air gas to the connected ventilator.When this happens, the ventilator switches to 100% oxygen supply as per design.The alarms ¿o2 concentration high¿ and ¿low air gas supply¿ will be generated by the connected ventilator device, and the compressor will generate an audible alarm to alert the operator.The event was investigated at the hospital by our field service engineer.The reported problem was resolved by replacing the compressor standby valve.Our previous in-house investigations have shown that particles in the standby valve, such as brass residuals or a worn out rubber sealing causes these kind of symptoms (cycling in and out of standby mode).No more issues have been reported since the repair was preformed by our field service technician.
Event or Problem Description
Manufacturer ref.#: (b)(4).

• Brand Name: COMPRESSOR MINI
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 7082241
• Report Number: 8010042-2017-00602
• Device Sequence Number: 1096300
• Product Code: BTI
• Combination Product (Y/N): N
• PMA/510(K) Number: K023354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6481787
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1