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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 200
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ARJO HOSPITAL EQUIPMENT AB SYSTEM 200 Back to Search Results
Model Number AP31200-EU
Device Problems Biofilm coating in Device (1062); Microbial Contamination of Device (2303); Environmental Compatibility Problem (2929)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2014
Event Type  malfunction  
Event Description
The event in complaint (b)(4) has described to us as follows by the arjohuntleigh representative who visited the customer site and inspected the device, as documented in the complaint file: "legionella flush performed".Additional information provided by the originator."it was found low legionella.After flushing result ok".From the information received there is no indication that any injury occurred to the patient or caregiver.Mfr - 9611530-2014-00048.
 
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Brand Name
SYSTEM 200
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 2412 1
SW  24121
Manufacturer (Section G)
ARJO, INC.
50 north gary ave., suite a
roselle IL 60172 168
Manufacturer Contact
50 north gary ave., suite a
roselle, IL 60172-1684
MDR Report Key3952673
MDR Text Key4644717
Report Number1419652-2014-00181
Device Sequence Number1
Product Code ILM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/11/2014,06/16/2014
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 Other
Device Model NumberAP31200-EU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/11/2014
Distributor Facility Aware Date06/16/2014
Device Age12 YR
Event Location Nursing Home
Date Report to Manufacturer07/11/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/11/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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