MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number 393-800

Device Problems Overheating of Device (1437); Unexpected Shutdown (4019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Health professional should be "no information".

Event Description

According to the complaint, a field service engineer delivered an abl800 flex analyzer the (b)(6) 2020 at the customer site.The field service engineer stayed to observe that the analyzers started up, then planned the installation the following day and left.In the morning the (b)(6) 2020 the cleaning personnel noticed the smell of burned electricity.The laboratory personnel discovered that the analyzer had stopped working and there were no diodes or noise from it.

• Brand Name: ABL800 FLEX ANALYZER
• Type of Device: ABL800 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: ida rønshof ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 9774980
• MDR Text Key: 204016900
• Report Number: 3002807968-2020-00005
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2692N0009
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3002807968-03/04/20-004
• Patient Sequence Number: 1