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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 8000; BED, AC-POWERED ADJUSTABLE HOSPITAL
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ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 8000; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number 8000BA22A12BA
Device Problem Entrapment of Device (1212)
Patient Problem Injury (2348)
Event Date 06/17/2020
Event Type  Injury  
Manufacturer Narrative
The process of gathering information is ongoing.The results of the analysis will be provided upon conclusions of the investigation.
 
Event Description
Following information reported, during cleaning underneath the enterprise 8000 bed by the housekeeper, a facility staff member lowered the bed making the bed hit the housekeeper back/shoulder.As a consequence, she was subsequently signed off work for over 7 days.No more details regarding the injury sustained were provided.
 
Manufacturer Narrative
It was reported to arjo by the end-user that during cleaning under the bed by the housekeeper, a facility staff member pushed the button on the control panel and lowered the platform that hit the housekeeper¿s neck and top of the shoulders causing pain.The housekeeper was out of work for over 7 days.Arjo was informed two months after the incident.The facility confirmed that there were no bed¿s failures observed.The bed is still being used within the facility.When reviewing similar reportable events for the last 5 years, no other complaint was found with a similar description.This is an isolated occurrence.To conclude, the device played a role in the event as the bed platform lowered on the user cleaning under the bed.The facility staff confirmed that there was no device failure.The complaint decided to be reportable due to the impact of the housekeeper's neck and shoulders by the lowering bed platform.
 
Event Description
It was reported to arjo by the end-user that during cleaning under the bed by the housekeeper, a facility staff member pushed the button on the control panel and lowered the platform that hit the housekeeper¿s neck and top of the shoulders causing pain.The housekeeper was out of work for over 7 days.Arjo was informed two months after the incident.
 
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Brand Name
ENTERPRISE 8000
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks. piotra wawrzyniaka 2
komorniki PL-62 052
PL  PL-62052
MDR Report Key10435852
MDR Text Key204562122
Report Number3007420694-2020-00143
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8000BA22A12BA
Date Manufacturer Received08/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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