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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. NIMBUS PROFESSIONAL; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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ARJOHUNTLEIGH POLSKA SP. Z O.O. NIMBUS PROFESSIONAL; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number 651001DAR
Device Problem Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/31/2022
Event Type  malfunction  
Event Description
A malfunction of the nimbus professional mattress was reported to arjo by the customer staff.Following information gathered, the mattress was allegedly 'not properly inflated'.The patient rolled against the side rails.The patient was removed from the mattress and the device was excluded from use.No fall, and neither injury was claimed.
 
Manufacturer Narrative
Analysis of the claimed malfunction is ongoing to establish root cause of the event.Additional information will be provided upon conclusion of the investigation.
 
Manufacturer Narrative
The mattress involved in the claimed to be returned to the manufacturer to be inspected at the manufacturing site.It is currently in transit.Results of the evaluation will be provided to the follow-up report.
 
Manufacturer Narrative
The mattress involved in the claimed event was returned to the manufacturer on 27 feb 2023.During the evaluation, no issue was found.It inflated correctly.The investigation is in progress, the final conclusions will be forwarded within 30 days.
 
Manufacturer Narrative
A malfunction of the nimbus professional mattress was reported to arjo by the customer staff.Following information gathered, the mattress was allegedly 'not properly inflated'.The patient rolled against the side rails.The patient was removed from the mattress and the device was excluded from use.No fall, neither injury was claimed.The involved mattress was inspected by the arjo service technician.The claimed issue was not duplicated, no over-inflation was observed.The technician detected only disconnected cpr (cardio-pulmonary resuscitation) hose but it was not responsible for the claimed issue.The cpr hose disconnection from the cpr unit will cause the mattress deflation.The pump was also inspected and no issue was found.The claimed mattress was returned to the manufacturer and it was inspected again.The mattress inflated correctly, no issues were found.It is unknown why the customer observed mattress over-inflation as during the evaluation the mattress inflated correctly.The cause of the issue was not established.In summary, the mattress allegedly inflated incorrectly and from that perspective, the nimbus professional mattress did not meet the performance specification.The arjo device played role in the event as the mattress was in use at that time.No injury, neither fall occurred.The complaint was assessed as reportable due to the allegation "the mattress was not properly inflated because the patient rolled against the siderails".
 
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Brand Name
NIMBUS PROFESSIONAL
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks. piotra wawrzyniaka 2
komorniki PL-62 052
PL  PL-62052
Manufacturer (Section G)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks. piotra wawrzyniaka 2
komorniki PL-62 052
PL   PL-62052
Manufacturer Contact
justyna kielbowska
ks. wawrzyniaka 2
komorniki 62-05-2
PL   62-052
883337089
MDR Report Key16203583
MDR Text Key308769047
Report Number3005619970-2023-00001
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 04/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number651001DAR
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
Patient SexFemale
Patient Weight57 KG
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