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

Model Number C20

Device Problems Leak/Splash (1354); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when replacing a failing internal power backup battery, our company representative noticed that the battery had leaked battery acid into the battery compartment of the anesthesia workstation.There was no injury reported.(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 #:(b)(4).Getinge usa sales, llc (b)(4).Contact peron: (b)(4).The leaking power backup battery has not been available for investigation.The received logs show that alarms had been generated indicating that the battery was due for replacement as per service manual.The power backup battery is a sealed acid-lead rechargeable battery.Received images confirm the leakage at the upper joint but we are not able to determine the true cause of the leakage.

• Brand Name: FLOW-I-C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8451207
• MDR Text Key: 139979095
• Report Number: 8010042-2019-00202
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• 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
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1