MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number C30

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during patient treatment, the anesthesia workstation generated alarms for high airway pressure and high peep there was no patient harm.(b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: e2018003.Getinge usa sales, llc.45 barbour pond drive wayne, nj 07470.Contact peron: (b)(4).The anesthesia workstation was investigated on site by the hospital personnel, no fault was found.The expiratory patient tube showed signs of having been squeezed.The device logs were received and show that no system check out was performed on the date of the event.A successful system check out was performed 4 days after the event.The technical log has no recordings related to the event.The internal log contains clinical alarms such as regulation pressure limited and airway pressure: high, high continuous pressure and peep: high.We have not been able to determine why the alarms were generated but the combination of the alarms may be an indication of a blockage in the breathing circuit.

Event Description

Manufacturer ref #: (b)(4).

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8256431
• MDR Text Key: 133484871
• Report Number: 8010042-2019-00034
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1