MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH; BATH, SITZ, POWERED

Device Problem Component Falling (1105)

Patient Problems Concussion (2192); Injury (2348)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 arjohuntleigh has been initially notified about an incident that involves parker bath.It was indicated that while drying the patient the tub door came down and hit the caregiver on the head.As a result of the incident the caregiver suffered a concussion and whiplash.

Manufacturer Narrative

This report is being filed under exemption e2012070 by (b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment (b)(4) (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 (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).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 strut is adjusted to facilitate door opening and to keep the balance of the door in raised position, to avoid door falling.On 14-aug-2017 arjohuntleigh was notified about an incident with regards to parker bath.In the received complaint, it was reported that while drying a patient ((b)(6) years old female weighting approximately (b)(6) kg) the door of parker bath fell down and hit one of two caregivers on the head.The caregiver, who was hit on the head, finished her shift however the next day became more sore.Doctor's appointment revealed that the caregiver suffered a concussion and whiplash.Injured was recommended to take week off work.After the event, the bath was tested by acute care manager in accordance to arjohuntleigh service technician recommendations.The manager was told to hold the door at a 45 degree angle, after release, the door of the bath dropped quickly.After the functional test performance the presence of welded parker hinge was confirmed.The malfunction was found to be associated with faulty door strut and loose door bolt.The tub was taken out of service until the faulty part has been replaced and bolt has been retightened.According to the additional information provided we established that the door strut has never been replaced on the bath in question.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 recommended intervals.The instruction for use (ifu no 04.Al.00/4 us.Ca dated on april 2007) provided together with the involved device informs parker bath users 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." the following actions must be carried out in weekly intervals: "open and close the door and check the lock and supporting gas strut for correct function i.E.The door should not drop by itself.Examine the door seal for cuts, tears or distortion." if any malfunction would be noticed during the check, the qualified personnel service needs to be called for repair.The device cannot be used till the repair is completed.In accordance to preventive maintenance schedule included in ifu, qualified personnel is obliged to replace gas strut every 3 years.Ifu also specifies the intended use of the bath: "the equipment should only be used under the supervision of trained skilled staff in accordance with the instructions outlined in the operating and product care instructions.All other uses must be avoided.The equipment must only be used for the purposes stated above, and must be installed according to the recommendations given in the assembly and installation instructions.The normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in this manual." please note that this device was in use for almost 10 years, therefore there should be at least 3 scheduled replacements of a gas strut performed.Based on information provided within the complaint, the gas strut has not been replaced since manufacturing.It needs to be emphasized that the device in question was not under arjohuntleigh service contract.To prevent the incident from recurrence the awareness was issued by arjohuntleigh service technician to remind the site about necessity of replacing gas strut every 3rd year.It is considered to be a good practice.In summary, this complaint was decided to be reportable due to the allegation of the injury sustained by the caregiver as a result of tub's door falling.The parker bath was being used for patient handling at the time of the event and in that way contributed to the event.Upon the conducted investigation and bed inspection done by the arjohuntleigh representative, we were able to determine the exact cause of the issue occurrence which was found to be associated with lack of preventive maintenance.The tub's door was reported to fall and from that perspective, the parker bath did not meet manufacturer's specification.The received information and our evaluation as described above are showing that if parker's maintenance procedures were followed in accordance to the device instruction for use, there would be no patient or caregiver at risk.

• Brand Name: PARKER BATH
• Type of Device: BATH, SITZ, POWERED
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O.; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; verkstadsvagen 5; eslov, 24121 ; SW 24121
• MDR Report Key: 6796591
• MDR Text Key: 82753166
• Report Number: 3007420694-2017-00174
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• 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: 09/27/2017
• Distributor Facility Aware Date: 08/14/2017
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2017
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2007
• 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): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 91