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

Model Number C20

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the hospital staff noticed that the lid for the internal battery compartment was missing.There was no patient involvement.(b)(4).

Manufacturer Narrative

The problem description states that the battery lid cover for the battery compartment was not mounted at the factory.Our work instructions have been updated since this device was manufactured.Our conclusion is that the lack of (missing) battery lid cover was likely caused by a single assembly line operator error at the time.(b)(4).Ref.Exemption #: e2018003.(b)(4).(b)(6).

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: 7433002
• MDR Text Key: 105695787
• Report Number: 8010042-2018-00187
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K160665
• 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: 05/18/2018

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
• 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
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 05/18/2018
• Date Device Manufactured: 04/15/2016
• 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