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

Model Number C30

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anesthesia workstation failed the pressure transducer test during system check out.There was no patient connected to the anesthesia workstation at the time of the event.(b)(4).

Event Description

Manufacturer's ref #: (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 person: (b)(4).The anesthesia workstation was investigated on site by our field service engineer.The reported issues with failing pressure transducer test during system check out were reproduced and found to have been caused by a faulty inspiratory pressure transducer circuit board.The inspiratory pressure transducer circuit board was replaced and the anesthesia workstation was successfully tested and returned to clinical use.The received device logs confirm the reported issue.The investigation of the returned inspiratory pressure transducer circuit board found that the reported issue was caused by a defective pressure sensor on the inspiratory pressure transducer circuit board.The defective pressure sensor leads to the zero pressure offset being outside allowed limits.We have not been able to determine why the pressure sensor failed/broke.

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 7854980
• MDR Text Key: 119664318
• Report Number: 8010042-2018-00468
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K133958
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• 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: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1