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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 AL21010-EU
Device Problem Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2023
Event Type  malfunction  
Event Description
Arjo received a customer complaint for parker bath.During service visit at the customer site an arjo representative noticed that a parker bath's door was not staying up but was falling due to the failure of the gas strut.The circumstances of the malfunction are unknown.No patient involvement and no injuries or health consequences were reported by the facility.
 
Manufacturer Narrative
Please note that previous medwatch reports for this product may have been submitted under the registration number (b)(4).Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.
 
Manufacturer Narrative
Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.
 
Manufacturer Narrative
Arjo received a customer complaint for parker bath.During service visit at the customer site an arjo representative noticed that a parker bath's door was not staying up but was falling due to the failure of the gas strut.The circumstances of the malfunction occurrence are unknown.The facility did not indicate that the defective bath was not used with the patient.No injuries or health consequences were reported by the facility.The faulty part (gas strut) was replaced.The parker bath door can be opened by pulling the lever down and lifting the door up.The gas spring mechanism is designed to make it easily open the door and keep the door balanced in the raised position to avoid dropping.A tube with a compression spring inside assists the gas strut when opening the door.If either gas strut or compression spring is defect the door will not stay in position up.This gradual deterioration will be noticeable in daily use.The parker user manual (ifu;04.Al.01_9) reminds the customer to check the operation of the door on a weekly basis to detect any faults related to this assembly.Unintentional closing of the door and lack of resistance are symptoms noticeable when checking the device.Based on the very limited information received and the unknown circumstances of the gas strut malfunction, it was not possible to determine the exact cause of the failure.In summary, the device was not up to the manufacturer¿s specification due to faulty door part (gas strut).This complaint was decided to be reported to the regulatory authorities due to gas strut malfunction leading to bath¿s door falling and because the circumstances of the failure occurence are unknown.The facility did not indicate that the defective bath was not used with the patient.
 
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Brand Name
PARKER BATH
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
katarzyna bobrow
ks. wawrzyniaka 2
komorniki 62-05-2
PL   62-052
668046472
MDR Report Key17239576
MDR Text Key318311099
Report Number3007420694-2023-00158
Device Sequence Number1
Product Code ILJ
Combination Product (y/n)N
Reporter Country CodeAU
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,Followup
Report Date 08/25/2023
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 Model NumberAL21010-EU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/12/2023
Initial Date FDA Received06/30/2023
Supplement Dates Manufacturer Received06/12/2023
06/12/2023
Supplement Dates FDA Received07/27/2023
08/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2017
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;
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