MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. PARKER BATH; ILJ

Model Number AL14110-CA

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

Initially it was reported by the arjohuntleigh's representative that parker's bath door: "closing too fast".The malfunction was reported by the caregiver as an unplanned service (the customer doesn't have a maintenance agreement).Due to potential risk to the resident or caregiver, we find this complaint to be reportable in abundance of caution due to potential risk to the patient or caregiver.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for parker bath, we have found a number of other cases with similar fault description - door fell down.Please note that arjohuntleigh manufactured over (b)(4) parker baths to date.With the amount of sold devices and with comparison to the daily use of them the occurrence rate observed for complaints with this failure mode in last 5 years is considered to be low and acceptable.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of the specification - door falling down.The device was not being used for patient handling when the failure occurred, however we decided to report this complaint in abundance of caution.The described event (unplanned service) refers to the malfunction that can cause or contribute to serious injury based on events received in the past.Complained product is subject to wear and tear during use.To ensure that it continues to perform within its original specification, preventive maintenance procedures should be carried out at the intervals shown.List of recommended steps can be found also in instruction for use.Instruction for use (ifu) is provided with each device.Ifu (04.Al.00/4 us,ca from april 2007) provides information about correct and safe use of the device.It informs how to correctly operate the door and informs about care and maintenance of the device.Ifu warns in section 'care and maintenance': "the points on this checklist are the minimum the manufacturer recommends.In some cases due to heavy use of the product and exposure to aggressive environment, more frequent inspections should be carried out.Continuing to use this product without conducting regular inspections or continuing to use this product when a fault is found will seriously compromise the user and residents safety.Local regulations and standards may be higher than the manufacturers.Preventive maintenance specified in this manual can prevent accidents." in accordance to preventive maintenance schedule included in ifu, qualified personnel is obliged to replace gas strut every 3rd year.Please note that this device was in use for almost 5 years and there should be at least 1 scheduled replacement of a gas strut around november/december 2013, however from received information regarding maintenance of this parker bath, it wasn't replaced at all.The involved parker path is not under arjohuntleigh's service contract.We find this factor contributing to the reported failure.In accordance to above, we conclude that this incident was caused by user error - lack of maintenance: user didn't follow recommended maintenance procedure as stated in the instruction for use.The received information and our evaluation as described above are showing that if parker's maintenance procedures were followed in accordance to instruction for use, there would be no patient or caregiver at risk.

• Brand Name: PARKER BATH
• Type of Device: ILJ
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5110249
• MDR Text Key: 26986207
• Report Number: 3007420694-2015-00185
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Followup
• Report Date: 10/22/2015,08/31/2015

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 Caregivers
• Device Model Number: AL14110-CA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2015
• Distributor Facility Aware Date: 08/31/2015
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other