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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPIITAL EQUIPMENT AB MALIBU/SOVEREIGN; BATH, SITZ, POWERED
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ARJO HOSPIITAL EQUIPMENT AB MALIBU/SOVEREIGN; BATH, SITZ, POWERED Back to Search Results
Model Number AZR23110-GB
Device Problem Device Tipped Over (2589)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2019
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2018 arjo was notified about an event with the involvement of malibu bathtub, where it was reported that device almost tipped over during use.At the time when the event occurred the caregiver rotated patient out of the bath, the chair was lowered to allow patient's feet to touch the floor.While the bathtub was drained of water, the caregiver had dried the patient sitting on the bathtub chair then the device started to tip over.There was no injury reported.During device evaluation, the arjo representative found that bathtub was not properly fixed to the ground.The involved bathtub was commissioned by arjo in 2010, but according to the information received from the customer representative the bathroom was refurbished (floor covering was replaced), it required to remove the bathtub.It was reported by the customer that a 3rd party flooring contractor made bath re-installation.The arjo service technician during inspection established that during this re-installation the non-arjo technician used the original fixings which were damaged because the threaded inserts were missing.According to the instructions for use [operating and product care instructions ; 04.Az.00_2gb dated on april 2008] there is information that: "the equipment must be installed appropriately trained personnel according to the assembling and installation instructions (06.Az.00_1gb issued in april 2008 current at the time this device was manufactured).This installation manual provides instructions regarding proper floor fixtures installation and includes the following information reminding the need to use floor attachments: "to prevent the bath tub from falling over, the floor fixtures provided in the installation kit have to be used when installing malibu/sovereign.The floor construction must be suitable for anchoring the bolts." "when the work [installation] is completed check that: all details are mounted corresponding to the assembly instructions." moreover, to confirm that malibu/sovereign bathtub is correctly installed to the floor, the loading test should be performed on the transfer chair positioned outside of the tub.Following the installation manual (06.Az.00_1gb issued in april 2008), the weight of the applied test load (according to the maximum lifting capacity of the lift arm) should be 195kg (430 lbs) maintained on the bath chair for a minimum of 20 minutes.The bathtub should also be leveled by tightening the foot nuts against the floor fixtures.After the reported complaint, arjo service technician performed bathtub re-installation according to the manufacturer's specification described under assembly and installation instruction.The device was then returned to use.According to the collected information, bath was used for patient therapy when it almost tipped over.In light of this information the bath was not up to the manufacturer's specification.The complaint was decided to be reported to the competent authority basing on the allegation that the bathtub almost tipped over and this situation upon recurrence may pose a risk for a patient or caregiver.
 
Event Description
On (b)(6) 2018 arjo was notified about an event with the involvement of malibu bathtub, where it was reported that device almost tipped over during use.At the time when the event occurred the caregiver rotated patient out of the bath, the chair was lowered to allow patient's feet to touch the floor.While the bathtub was drained of water, the caregiver had dried the patient sitting on the bathtub chair then the device started to tip over.There was no injury reported.
 
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Brand Name
MALIBU/SOVEREIGN
Type of Device
BATH, SITZ, POWERED
Manufacturer (Section D)
ARJO HOSPIITAL EQUIPMENT AB
verkstadsvagen 5
eslov,
SW 
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 Key8844823
MDR Text Key199113056
Report Number3007420694-2019-00120
Device Sequence Number1
Product Code ILM
Combination Product (y/n)N
Reporter Country CodeUK
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 07/31/2019
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? Yes
Device Operator No Information
Device Model NumberAZR23110-GB
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/08/2019
Initial Date FDA Received07/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2010
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 Age89 YR
Patient Weight74
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