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

Model Number FLOW-I C20

Device Problems Battery Problem (2885); Chemical Problem (2893)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2020

Event Type  malfunction  

Event Description

It was reported that when unpacking a backup battery prior to a battery replacement as per service manual, the battery had been packed upside down and there was a leakage of battery acid.There was no harm reported.(b)(4).

Event Description

Manufacturer´s ref #: (b)(4).

Manufacturer Narrative

The received images show signs of battery acid on the battery and the wrapping (package).The battery has not been received for investigation.We have not been able to determine the true cause of the battery having been packed incorrectly.It is however likely that a single mistake during the packing process caused the reported issue.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9852477
• MDR Text Key: 189580565
• Report Number: 8010042-2020-00161
• 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: 04/16/2020

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: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1