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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYSER; ABL90 FLEX ANALYZER
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RADIOMETER MEDICAL APS ABL90 FLEX ANALYSER; ABL90 FLEX ANALYZER Back to Search Results
Model Number 393-090
Device Problem High Readings (2459)
Patient Problem Hypoxia (1918)
Event Date 05/05/2019
Event Type  malfunction  
Event Description
According to the complaint, customer samples were measured on an abl90 flex analyzer with the following result for po2: sample #(b)(6) / 2019-05-01 / 09:24h (measurement time) / analyzer serial number (b)(4) / 139 mmhg sample #(b)(6) / 2019-05-01 / 09:31h (measurement time) / analyzer serial number (b)(4) / 65.1 mmhg.However, the analyzer made an error message about the level of 139 mmhg.After a service inspection on 2019-05-05, another similar incident appeared: sample #(b)(6) / 2019-05-29 / 09:59h (measurement time) / analyzer serial number (b)(4) / 115 mmhg sample #(b)(6) / 2019-05-29 / 16:19h (measurement time) / analyzer serial number (b)(4) / 78.9 mmhg based on the measurements and the patient's condition, the customer reports the results of po2 115 mmhg as false high.
 
Manufacturer Narrative
Due to lack of information received from the customer, the root cause cannot be established.
 
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Brand Name
ABL90 FLEX ANALYSER
Type of Device
ABL90 FLEX ANALYZER
Manufacturer (Section D)
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej, 2700
DA  2700
MDR Report Key8690519
MDR Text Key207716505
Report Number3002807968-2019-00024
Device Sequence Number1
Product Code CHL
UDI-Device Identifier05700693930909
UDI-Public(01)05700693930909
Combination Product (y/n)N
PMA/PMN Number
K160153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number393-090
Device Catalogue Number393-090
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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