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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800
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RADIOMETER MEDICAL APS ABL800 Back to Search Results
Model Number 393-800
Device Problem High Readings (2459)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2022
Event Type  malfunction  
Event Description
On 31-may-2022, 10:22pm the abl800 (serial number: (b)(4)) reported a result for na+ of 174 mmol/l.Same day at 10:29pm a comparison result on another abl analyzer was 137 mmol/l.The customer reported the first result as false high.According to the complaint, there was no harm to the patient.
 
Manufacturer Narrative
The problem was solved by replacing the na-electrode with a new.After this, abl800 analyzers reported similar values on same sample.Thus, the root cause can be identified as failure of the na-electrode.
 
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Brand Name
ABL800
Type of Device
ABL800
Manufacturer (Section D)
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej, 2700
DA  2700
Manufacturer (Section G)
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej, 2700
DA   2700
Manufacturer Contact
tom engdahl
aakandevej 21
broenshoej, 2700
DA   2700
MDR Report Key14684100
MDR Text Key294142791
Report Number3002807968-2022-00020
Device Sequence Number1
Product Code CHL
UDI-Device Identifier05700693938011
UDI-Public(01)05700693938011(10)754R2564N006
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K041874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number393-800
Device Catalogue Number393-800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/26/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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