MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20; GAS-MACHINE, ANESTHESIA

Model Number C20

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

More information surrounding the event has been sought.A supplemental medwatch report will be provided when the investigation is finished.

Event Description

It was reported that the internal battery of the anesthesia system was found defective and acid was leaking out.There was no patient involvement.There were no injuries reported.(b)(4).

Manufacturer Narrative

(b)(4).The anesthesia workstation was investigated by the company field service engineer at the hospital and the battery and the battery bracket were replaced due to acid leakage.The battery could not be returned for investigation due to the damages and acid leakage.The received logs does not cover the date of the event but they confirm technical errors codes indicating a weak battery prior to the reported event date.Based on the limited amount of information and without the battery to investigate, we are unable to determine the cause of the battery damages.

Event Description

(b)(4).

• Brand Name: FLOW-I C20
• 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: 5155781
• MDR Text Key: 28911379
• Report Number: 8010042-2015-01031
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1