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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SYSTEM 2000; BATH, HYDRO-MASSAGE

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ARJOHUNTLEIGH POLSKA SP. Z O.O. SYSTEM 2000; BATH, HYDRO-MASSAGE Back to Search Results
Model Number AP31211EU1011
Device Problem Sharp Edges (4013)
Patient Problem Laceration(s) (1946)
Event Date 04/27/2023
Event Type  Injury  
Event Description
Arjo was notified of an incident involving a system 2000 bathtub.According to information provided while performing annual preventive maintenance at the customer's site, an arjo service technician injured his forearm.He tried to remove the cartridge.The top of the cartridge popped out and, while attempting to remove it, the technician injured his forearm on the inner metal plate that goes along the bathtub.The injury required a suture on the forearm.
 
Manufacturer Narrative
The investigation is ongoing and further information will be provided upon conclusion of the investigation.
 
Manufacturer Narrative
According to the information gathered, an arjo service technician was injured while performing annual preventive maintenance of the system 2000 bathtub at the customer's site.The top of the cartridge popped out and, while attempting to remove it, the technician injured his forearm on the inner metal plate that goes along the bathtub.The injury required a suture on the forearm.The inner metal plate that goes along the bathtub is located inside the bath panel and is only accessible to service technicians while inspecting or repairing the device.Therefore, caregivers and patients do not have access to this component.The photographic evidence and information gathered in the course of this investigation were consulted with the technical department.It seems most likely that the sharp edges on the inner metal plate was a result of non-conform part delivered from the supplier.The edges of this part should be blunted after laser cutting.However, this component had sharp edges and no signs of any processing on this part can be seen.Arjo device failed to meet its performance specification since the edge of the metal part was sharp and not dulled.The device was not used for a patient treatment at the time of the event.The complaint was decided to be reportable due to serious injury reported.
 
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Brand Name
SYSTEM 2000
Type of Device
BATH, HYDRO-MASSAGE
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 Key17001539
MDR Text Key315916348
Report Number3007420694-2023-00109
Device Sequence Number1
Product Code ILJ
UDI-Device Identifier05055982713566
UDI-Public(01)05055982713566(11)201116
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberAP31211EU1011
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/27/2023
Initial Date FDA Received05/25/2023
Supplement Dates Manufacturer Received04/27/2023
Supplement Dates FDA Received06/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2020
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) Required Intervention;
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