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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

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ARJOHUNTLEIGH POLSKA SP. Z O.O. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number PXB001DAR
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unclear Information (4052)
Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)
Event Date 08/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Additional information will be provided upon the investigation conclusion.
 
Event Description
Arjo was notified by a customer that a patient fell out of the bed during the night.It was indicated that the safety sides were not in high position.
 
Manufacturer Narrative
Currently, we are still in the process of gathering additional information regarding the circumstances of the reported event.Further information will be provided upon conclusion of the investigation.
 
Manufacturer Narrative
Investigation has been carried out onto this incident and conclusions are following.Arjo was informed about a patient fall while on arjo auto logic mattress and non-arjo bed frame (brand name unknown).The customer stated that the event occurred when the patient was sleeping and that the safety sides were not raised.Specific patient medical condition was not provided.No allegation of product malfunction was reported by the customer.No failure was detected in the arjo service center when the system returned from rental, either.The product user guide instruction for use (ifu) number (b)(4) warns: "it is responsibility of the care giver to ensure that the user can use this product safely." "whilst the patient is unattended, the decision to use safety sides should be based on clinical assessment and in line with local policy".When reviewing reportable complaints for patient fall, we have found some incidents of patient fall, and 10 incidents have been reported by the one group of facilities from french market.After the events, arjo takes this matter very seriously and this is why arjo quality director for french market contacted the customer to help working on identifying the root cause of the issue.The customer facility representative stated that they are considering assessing patients on admit in order to select air mattresses for individual patient's needs.In summary, the auto logic system was used to treat the patient, for this reason, it played a role in this incident, however there was no allegation of device malfunction, the mattress did not fail to meet its specification.The circumstances of the event are unknown, it is unknown why the safety sides were not raised, what is the patient medical condition, what type of bed frame was used.Therefore is not possible to determine the exact root cause of patient fall.We report this event because of allegation of patient fall, which may lead to serious health consequences.
 
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Brand Name
AUTO LOGIC
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks. wawrzyniaka 2
jiangsu
komorniki, 62-05 2, P
PL  62-052, PL
MDR Report Key8159357
MDR Text Key131311363
Report Number3005619970-2018-00017
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 01/31/2019
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 Lay User/Patient
Device Model NumberPXB001DAR
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/31/2019
Distributor Facility Aware Date11/19/2018
Device Age6 YR
Event Location Hospital
Date Report to Manufacturer01/31/2019
Initial Date Manufacturer Received 11/19/2018
Initial Date FDA Received12/13/2018
Supplement Dates Manufacturer Received11/19/2018
11/19/2018
Supplement Dates FDA Received01/11/2019
01/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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