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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER
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RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER Back to Search Results
Model Number 393-090
Device Problems Insufficient Information (3190); Patient Data Problem (3197)
Patient Problem No Patient Involvement (2645)
Event Date 07/03/2019
Event Type  malfunction  
Manufacturer Narrative
Should be no information.This case is related to 3002807968-2019-00030 with patient identifier (b)(6).
 
Event Description
According to the complaint, a customer experienced retransmission of patient data with wrong times and dates in the neonatal ward.According to the customer, this was done spontaneously without any intervention of the medical staff.Blood gas results done on june 28th at 8:02 were re transmitted into patient file on july 3rd at 3:07 and 3:08 am.Blood gas results done on july 1st at 9:01 am were re transmitted into patient file on july 3rd at 3:14.The hospital decided to disconnect the abl 90 from the hospital net.
 
Manufacturer Narrative
It has come to radiometer medicals attention that the udi code provided was wrong.The udi code has been corrected in this report.Radiometer has not been able to acquire the requested data from the customer and therefore no investigation was performed.Radiometer considers this case closed.
 
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Brand Name
ABL90 FLEX ANALYZER
Type of Device
ABL90 FLEX ANALYZER
Manufacturer (Section D)
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej, 2700
DA  2700
MDR Report Key8802280
MDR Text Key204371529
Report Number3002807968-2019-00031
Device Sequence Number1
Product Code CHL
UDI-Device Identifier05700693930909
UDI-Public(01)05700693930909
Combination Product (y/n)N
PMA/PMN Number
K092686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
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 Received11/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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