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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 9000X; BED, AC-POWERED ADJUSTABLE HOSPITAL
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ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 9000X; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number 9611AF101BCUSB
Device Problem Use of Device Problem (1670)
Patient Problem Head Injury (1879)
Event Type  Injury  
Manufacturer Narrative
The investigation is ongoing.The results of the analysis will be provided to the follow-up report.
 
Event Description
On (b)(6) 2019 arjo was informed about the event which occurred in (b)(6) in the us.Following information reported the patient fell out of the enterprise 9000x bed and suffered head injury with possible brain bleed.No device malfunction was found during device evaluation.The bed passed all functionality tests.
 
Manufacturer Narrative
On 26 dec 2019 arjo was informed about the event with the participation of enterprise 9000x bed.The patient fell out of the bed and as a result sustained head injury with a possible brain bleed.After this event, the patient was taken to the emergency room for care.Based on the information provided by the facility staff this incident was internal neglect from the hospital personnel and the customer confirmed the arjo bed did not cause or contribute to the patient's fall.The patient movement detection system of enterprise 9000x bed was off when this incident occurred.This system detects undesired patient movement and activates the alarm which can be easily heard by the facility staff e.G.At the nurse¿s station.The facility refused to provide any additional information regarding this incident, therefore the circumstances of the event could not be clearly determined.The device evaluation conducted by arjo technician confirmed that the patient movement detection alarm was not activated.The functional testing revealed that there were no issues with a bed, it was working in accordance with the specification.The product instructions for use (#746.591-en-12 dated on dec 2018) contains all crucial information and warnings which should be followed to ensure patient safety: ¿to reduce the risk of injury due to falls, lower the bed to minimum height when the patient is unattended¿.¿to ensure the patient can use the bed safely, their age and condition should be assessed by a clinically qualified person¿.If the recommendations mentioned above are followed up by the end-user, the risk of any hazardous situation is minimized.In light of the information gathered through the device evaluation and communication with the facility staff, the cause of the event cannot be confirmed.It should be pointed out that no malfunction within the bed was detected after the event, the customer confirmed the arjo bed did not cause or contribute to the patient's fall.In conclusion, the enterprise 9000x bed was being used for patient care at the time of the event.There was no product malfunction and from that perspective, it can be assumed that at the time the patient¿s fall the bed was working up to the manufacturer¿s specification.The complaint decided to be reportable due to the information of patient's fall resulted in a possible brain bleed.
 
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Brand Name
ENTERPRISE 9000X
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 Key9615958
MDR Text Key189595313
Report Number3007420694-2020-00010
Device Sequence Number1
Product Code FNL
UDI-Device Identifier05055982755030
UDI-Public(01)05055982755030(11)190328
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 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number9611AF101BCUSB
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
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