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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVEREIGN; BATH, HYDRO-MASSAGE
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ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVEREIGN; BATH, HYDRO-MASSAGE Back to Search Results
Model Number AZL23110-GB
Device Problem Device Tipped Over (2589)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2024
Event Type  malfunction  
Event Description
Arjo was notified of an event involving a malibu bathtub.It was reported that the bathtub tipped over when the resident was sitting on the bath chair (an integral part of the bathtub).It was indicated that while supporting the resident's legs, the bath chair began to lower.A loud noise was heard and the resident fell to the ground.No injuries were sustained by the resident.
 
Manufacturer Narrative
The investigation is ongoing and further information will be provided upon conclusion of the investigation.
 
Manufacturer Narrative
Arjo was notified of an event involving a malibu bathtub.It was reported that the bathtub tipped over when the resident was sitting on the bath chair (an integral part of the bathtub).It was indicated that while supporting the resident's legs, the bath chair began to lower.A loud noise was heard and the resident fell to the ground.No injuries were sustained by the resident.The device was inspected by an arjo representative.All operational functions of the bath were working correctly.It was noted that the tub foot attachment opposite the chair was bent and no longer held the tub foot in place.For this reason, the bathtub slipped out of its mount and fell over.Based on the device inspection results, the post-market surveillance data and consultation with the arjo technical department, we came to the conclusion that the issue reported seems to be related to normal wear of the component.The malibu bath involved in the event was manufactured about 12 years before this malfunction occurred.The equipment is subject to wear and tear, and recommended maintenance instructions must be performed when specified to ensure that the equipment remains within its original manufacturing specification.Following the instruction for use (ifu) for malibu bath (04.Az.00_8): ¿the expected life of this equipment, unless otherwise stated, is ten (10) years, subject to preventive maintenance being carried out in accordance with the care and preventive maintenance found in the ifu.¿ additionally, the ifu in the section "care and preventive maintenance" includes the caregiver's obligations to check the bath mechanical attachments on weekly basis.Due to malfunction reported, the bathing system did not meet the performance specification.The bath was used with the resident when the event occurred.The complaint was decided to be reportable to the competent authorities due to the bathtub tipping over, which led to the resident's fall.
 
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Brand Name
MALIBU/SOVEREIGN
Type of Device
BATH, HYDRO-MASSAGE
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 24121
SW  24121
Manufacturer (Section G)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 24121
SW   24121
Manufacturer Contact
justyna kielbowska
ks. wawrzyniaka 2
komorniki 62-05-2
PL   62-052
883337089
MDR Report Key18863129
MDR Text Key337196966
Report Number3007420694-2024-00068
Device Sequence Number1
Product Code ILJ
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 03/14/2024
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 Other
Device Model NumberAZL23110-GB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/09/2024
Initial Date FDA Received03/08/2024
Supplement Dates Manufacturer Received02/09/2024
Supplement Dates FDA Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2012
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 Age43 YR
Patient SexFemale
Patient Weight113 KG
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