Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z.O.O. ENTERPRISE 9000
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARJOHUNTLEIGH POLSKA SP. Z.O.O. ENTERPRISE 9000 Back to Search Results
Model Number 9000KD64CON1511
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Physical Entrapment (2327)
Event Date 02/26/2014
Event Type  Injury  
Event Description
It has been indicated by the customer that "patient blocked his leg on safety side." as the originally provided info were very limited, the arjohuntleigh rep visited the user's facility in order to inspect the claimed device.It has been confirmed that during the manual transfer of the patient from the bed to the chair, his/her foot became trapped between lowered safety side panels and the floor.The pt suffered hematoma on the foot, while the caregiver who attempted lifting the 90 kg pt and 185 kg bed (when helping the patient after entrapment), suffered a back injury.Reference mfr report number: 3007420694-2014-00037.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENTERPRISE 9000
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z.O.O.
ul. ks. piotra wawrzyniaka 2
komornikl
PL 
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 Key3773602
MDR Text Key4435120
Report Number1419652-2014-00090
Device Sequence Number1
Product Code FNL
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number9000KD64CON1511
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/02/2014
Distributor Facility Aware Date03/03/2014
Event Location Hospital
Date Report to Manufacturer04/02/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age70 YR
Patient Weight90
-
-