MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX, 393-800

Model Number 393-800

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event is estimated.

Event Description

According to the complaint, the waste container swelled without issuing alarm.When it was removed, the waste fluid inside flood out with pressure and caused damage to electronic parts.

Manufacturer Narrative

The analyzer was checked and cleaned.After replacing the cpu unit and printer unit the analyzer worked normally again.No further information has been received and it has therefore not been posible to find the root cause.

• Brand Name: ABL800 FLEX, 393-800
• Type of Device: ABL800 FLEX, 393-800
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 9810295
• MDR Text Key: 200814885
• Report Number: 3002807968-2020-00008
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2466N005
• Combination Product (y/n): N
• PMA/PMN Number: K041874
• 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: 09/24/2020

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: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1