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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE
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ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE Back to Search Results
Model Number AR52101-EU
Device Problem Unintended Movement (3026)
Patient Problem Pain (1994)
Event Date 06/28/2019
Event Type  Injury  
Manufacturer Narrative
Arjo was informed about an event with the involvement of system 2000 bathtub.It was reported that when the caregiver tried to lower the bath to the lowest positon, suddenly the bath stop functioning.The caregiver was not able to activate the bath function once again by pushing the lowering button on the control panel.After few seconds the bathtub lowered unintentionally about 30 cm to the lowest position with noise.As a consequence of the event the patient sustained back pain.On (b)(6) 2019 the bathtub was evaluated by the arjo representative.No visible damage was noticed.The hydraulic system was checked and tested in use, there was no oil leakage.The functional inspection showed that no malfunction was detected.During interview with customer it was confirmed that patient sustained back and hip injury.The hospitalization was required.Moreover, it needs to be emphasized that at the time of the malfunction, the device was in use for over 18 years (invoice date of claimed bath is year 2001).The instruction for use for system 2000 indicated that: "the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the operating and daily maintenance instruction, assembly and installation instructions and the spare parts catalogue." despite the effort made and test performed to duplicate the reported issue, arjo technician could not determine the cause.For this reason, the exact root cause cannot be explained.In summary, the device played a role in the event as it was used for patient therapy during the event.Although the device was up to its technical specification (as no malfunction that could have caused or contributed to the issue was detected), during the incident the device was reported by the customer to activate lowering function by itself and from that perspective did not meet its performance specification.The complaint has been reportable due to serious injury sustained by patient as an outcome of the event.
 
Event Description
Arjo was informed about an event with the involvement of system 2000 bathtub.It was reported that when the caregiver tried to lower the bath to the lowest positon, suddenly the bath stop functioning.The caregiver was not able to activate the bath function once again by pushing the lowering button on the control panel.After few seconds the bathtub lowered unintentionally about 30 cm to the lowest position with noise.As a consequence of the event the patient sustained back pain.
 
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Brand Name
SYSTEM 2000
Type of Device
BATH, HYDRO-MASSAGE
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov, 24121
SW  24121
Manufacturer (Section G)
ARJO HOSPIITAL EQUIPMENT AB
verkstadsvagen 5
eslov,
SW  
Manufacturer Contact
stolinska
ks. wawrzyniaka 2
komorniki, 62-05-2
PL   62-052
MDR Report Key8810836
MDR Text Key151705120
Report Number3007420694-2019-00118
Device Sequence Number1
Product Code ILJ
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 07/22/2019
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 No Information
Device Model NumberAR52101-EU
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/01/2019
Initial Date FDA Received07/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/24/2001
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight60
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