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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. PARKER BATH; BATH, HYDRO-MASSAGE
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ARJOHUNTLEIGH POLSKA SP. Z O.O. PARKER BATH; BATH, HYDRO-MASSAGE Back to Search Results
Model Number AL21000-GB
Device Problem Unintended System Motion (1430)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 11/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab (under registration #(b)(4)).As of 2014 that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).Additional information will be provided within the next report.
 
Event Description
It was reported that caregiver was bathing the patient, when the door opened and the water flooded out.The caregiver caught the patient to stop her falling out of the bath.The patient did not sustain injury.The caregiver jarred her shoulder, when catching the patient.The caregiver taken pain killers.No malfunction of the bath was detected.According to the collected information the door was not locked fully and opened while the caregiver was on the other side of the bath.
 
Manufacturer Narrative
It was reported that caregiver was bathing the patient, when the door opened and the water flooded out.The caregiver caught the patient to stop her falling out of the bath.The patient did not sustain injury.The caregiver jarred her shoulder, when catching the patient.The caregiver taken painkillers.According to the collected information the door was not locked fully and opened while the caregiver was on the other side of the bath.As per the reported information the bath door opened during use.During the evaluation performed by the arjo representative no malfunction of the device was detected and the bathtub was functioning according to the manufacturer's specification.According to the performed on-site interview the involved caregiver was not aware of the door lock on the bath.As a result the door was not locked fully and opened while the caregiver was on the other side of the bath.The parker bath is intended for assisted bathing and showering of adult residents in care facilities.The bath must be used by appropriately trained caregivers with adequate knowledge of the care environment, its common practices and procedures, and in accordance with the guidelines and safety instructions in the instructions for use (ifu; 04.Al.01_9gb issued in january 2015) delivered with each device.The parker bath has a door handle that works as a door lock.The door handle needs to be aligned with the sticker showing an open or closed lock.According to the ifu: - to unlock the door: press the door handle down until aligned with the sticker showing an open lock.- to lock the door: press the door handle up until the handle is aligned with the sticker showing a closed lock.(this may require some physical force).The ifu provides the instructions how to use door together with the supporting pictures.Based on the performed investigation we deem this event to be caused by combination of two factors - user not following ifu and wrong handling of the device.In summary, according to the customer allegation, the bath door opened during use, which nearly caused a patient fall.As per the description of event the device was not according to the manufacturer's specification as door should remain open.This complaint was decided to be reported to the competent authorities due to the information that patient almost fell out of the device and that the minor injury occurred.Please note that field h.4.Was updated as wrong value was sent within the initial report.
 
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Brand Name
PARKER BATH
Type of Device
BATH, HYDRO-MASSAGE
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ks. wawrzyniaka 2
komorniki, 62-05 2
PL  62-052
MDR Report Key7517579
MDR Text Key129312935
Report Number3007420694-2018-00225
Device Sequence Number1
Product Code ILJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 12/18/2018
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 NumberAL21000-GB
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/18/2018
Distributor Facility Aware Date11/08/2018
Device Age2 YR
Event Location Nursing Home
Date Report to Manufacturer12/18/2018
Initial Date Manufacturer Received 11/08/2018
Initial Date FDA Received05/16/2018
Supplement Dates Manufacturer Received11/08/2018
Supplement Dates FDA Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age80 YR
Patient Weight60
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