MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. PARKER BATH

Model Number AL11110-CA

Device Problems Component Falling (1105); Device Maintenance Issue (1379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

Event Type  malfunction  

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 w/similar fault description - "door fell down".We have been able to establish that there is decreasing complaint trend concerning these kinds of events.Pls note that arjohuntleigh manufactured over (b)(4) parker baths to date.With the amount of sold devices and w/comparison to the daily use of them, the occurrence rate observed for complaints w/this failure mode in the last 5 yrs., is considered to be low and acceptable.The device was inspected by an arjohuntleigh rep at the customer site and found to be out of the specification; defective and worn gas strut.The device was being used for patient handling and in that way contributed to the event.Product instruction for use (ifu) is provided w/each device.Ifu: 04.Al.00/3 gb from november 2005, informs: "the normal useful life of this equipment, unless otherwise stated, is ten years, subject to required preventative maintenance as specified in this manual.Preventive maintenance schedule (pms), is included in product ifu.The equipment is a subject for wear and tear and the maintenance instructions must be performed when specified to ensure that the equipment remains within its' original mfr's specification.This includes: check of door lock and operation by a caregiver every week and replacement of door gas strut by a qualified personnel every 3rd yr.The received info showed: the strut had never been replaced, bath was in use for about 9 years, bath wasn't under arjo's service contract for about 6 years after the manufacturing date, around year 2012, the customer signed service contract w/ arjo, last maintenance was performed in november 2014, the gas strut was examined then and found to be "intact".Bath was sold in (b)(6) 2012 and installed in (b)(6) 2012, bath has been regularly serviced since (b)(6).2012.Pls note that taking into consideration date of re-installation of a bath and start of service contract by arjohuntleigh, gas strut replacement should be scheduled around (b)(6) 2015, and the date of the reported event is (b)(6) 2015.Within this time, the involved bath wads checked and served in regular basis, this includes door operation and gas strut.The arjohuntleigh service and checks started from the assumption that the device was correctly maintained against its' labeling, up until the point where arjohuntleigh started doing service.In accordance to above info, we conclude that this incident was caused by user error; lack of maintenance before service contract w/arjo: gas strut wasn't replaced as recommended by the manufacturer.This conclusion is in line w/other similar complaints rec'd to date.The rec'd info showed also that the involved staff was aware about not correctly functioning door.: "the caregiver mentioned she felt the door felt heavy, but since no one had reported any issue prior she went ahead and gave the bath".The user did not mitigate risk by putting the device out of the service.The received info and our evaluation as described above are showing that if parker's maintenance procedures were followed in accordance to instruction of use, there would be no patient or caregiver at risk.(b)(4).

Event Description

Initially it was reported by the arjohuntleigh's representative that parker's bath door fell onto caregiver during use: "information from the site is that the door fell on her back while she was giving a resident a bath, she had the door open and the tub in the upright position, and the door fell on her back while she was bent over in the tub undoing the sling." the injured caregiver advised to see the doctor for check-up only.No other medical intervention was required.

• Brand Name: PARKER BATH
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 62052 ; PL 62052
• Manufacturer Contact: pamela wright ; 1265 wetmore ste. 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4999550
• MDR Text Key: 25488722
• Report Number: 3007420694-2015-00154
• Device Sequence Number: 1
• Product Code: ILM
• 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: Notification
• Report Date: 08/11/2015,07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AL11110-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: 08/11/2015
• Distributor Facility Aware Date: 07/20/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/11/2015
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2006
• 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