MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH; BATH, HYDRO-MASSAGE

Model Number AL14500-GB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Head Injury (1879); Headache (1880); Concussion (2192)

Event Date 08/23/2014

Event Type  Injury  

Manufacturer Narrative

This report is being filed under exemption (b)(6) by arjohuntleigh polska sp.Z o.O.(registration (b)(4) on behalf of the importer (b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (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 upon conclusion of the investigation.

Event Description

Arjohuntleigh was informed about the incident with parker bath door that happened in (b)(6) 2014.According to the letter received on (b)(6) 2017 a nurse was assisting a patient to get into a parker bath when after opening the doors of the bath fell and hit a nurse on the head.As a consequence a nurse suffered, and continues to suffer, severe personal injuries, loss, damage, inconvenience and expense.

Manufacturer Narrative

The investigation has been carried out and the conclusions are following.Arjohuntleigh was notified about the incident described in the solicitor letter.As per the letter, the nurse was assisting a patient to get into a parker bath, when after opening the doors "suddenly and without warning the doors of the bath fell and hit her on the head." as a result a nurse sustained musculo-ligamentous injuries to neck, musculo-ligamentous injuries to upper back, concussion, head injury, headaches.The nurse had blood pressure measured which was stated as high.No fracture was detected, a neurosurgery consultant advised after ct scan that "everything seemed satisfactory", the nurse was advised that the neck pain would resolve in time.After continues pain in neck, back, jaw and ear, the nurse had an mri and a jaw x-ray, which showed degenerative changes in neck at c5/6 level and c6/7 level with central and left sided disc herniation and compromise of the left c7 nerve root.This generative changes were asymptomatic prior to the incident.An indication in the letter is that the nurse is still suffering from headaches, although not as frequent and severe.The nurse returned to work on (b)(6) 2014.Parker bath is intended for assisted bathing and showering of adult residents in care facilities.It is equipped with a full-length side opening door for easy access of mobile patients.The door can be opened by pulling the lever down and lifting the door up.The gas spring is adjusted to facilitate door opening and to keep the balance of the door in raised position, to avoid door falling.After the incident an arjohuntleigh technician visited the facility per the customer request to inspect the bath.The technician did not find any fault, the bath was operating correctly.The door were multiple times fully tested in a normal down position and lilted position and no failure could be detected.Also doors on all the other baths in the facility were inspected and no issue was found.Prior to incident the bath was subjected to a regular service inspection by arjohuntleigh service technicians on the 2014-may-13 and no faults were detected.Few months later, on (b)(6) 2014 following the customer call, a repair was done for an air jet cap and diaphragm missing and a pop up waste assembly was broken.This however is not related to the reported issue.After the repair the bath was tested and it was confirmed operating correctly.A review of complaint history for parker baths revealed that failure rate for the investigated issue is remote.In order to establish possible root cause of the event, we have looked at the previous complaint for parker door falling, it was possible to list several root causes : gas strut failure.The screw came loose from the hinge resulting in detachment of gas strut.Compression spring failure.Opening door when the bath is in reclined position.We have excluded first three failures (a, b & c) as it was confirmed that door was operating per manufacturer specification prior and after the incident.The bath can be used in upright position, as well as in reclined position for better bathing experience, or for residents with no capacity to support themselves at all.Patient transfer when the bath is in a reclined position is allowed only for dependent residents, using a ceiling lift.In this kind of transfer the door shall remain closed all the time, otherwise they will fall under gravity.The instructions for use, which is delivered with each device (ifu, document number (b)(4) dated on april 2007) provides safety instructions and description how to use door: "never recline the bath unless the door is in the closed position"."transfer the bather 3.Open the access door by pulling down on the door handle.Raise the door to the fully open position." it appears highly possible that the bath was in reclined position when the door was opened thus resulting in its fall.The above deliberations, however, cannot be confirmed with certainty as no more details from the customer site were provided despite several attempts were made by arjohuntleigh representative.Looking at the incident scenario it has been established that the parker bath was being used for patient hygiene at the time of the event and from this perspective was directly involved with the reported incident.Although not fault within the device was found (met the manufacturer's specification), it has been deemed that it failed to meet performance specification as door fell, were not holding upright position and hit the nurse's head.In a result the nurse sustained a personal injuries, assessed by arjohuntleigh clinical expert as serious.For this reason we have decided to report this event.

• Brand Name: PARKER BATH
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 , SW; SW 24121, SW
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 , SW; SW 24121, SW
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 6788085
• MDR Text Key: 82598999
• Report Number: 3007420694-2017-00173
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: AL14500-GB
• 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: 09/29/2017
• Distributor Facility Aware Date: 04/10/2017
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/29/2017
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• 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
• Patient Age: 44 YR