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

Model Number AL11110-CA

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(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 (b)(4)).As of 2014 that number was de-activated due to the site no longer being manufactured and shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under (b)(4).

Event Description

Arjohuntleigh received a customer complaint on parker bath, where it was reported that the tub door was falling heavily.According to the provided information no patient was involved in the event.Neither patient nor caregiver were injured.

Manufacturer Narrative

Parker bath is intended for assisted bathing and showering of adult residents in care facilities.It is equipped with a full-length side opening 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.On 2017-nov-10 arjohuntleigh representative received a customer complaint on parker bath (model 420), where it was reported that the tub door was falling heavily.According to additional information reported to arjohuntleigh representative, the customer facility staff was aware of the door malfunction (the door had not kept up position properly).Based on information provided, no patient was involved in the event.Neither patient nor caregiver was injured.On 2017-nov-14 the arjohuntleigh representative visited the facility and evaluated the device.It was found that the door gas strut had broken off at the bottom connector (pivot knuckle) making the door unable to remain open as there was no connection between gas strut and door hinge.Despite our best efforts, the further analysis was not possible as the faulty door gas strut was disposed.Based on the information provided by arjohuntleigh representative the gas strut was previously replaced in september 2015, which means that part was over 2 years in use.According to operating and product care instructions (04.Al.00/3 dated on november 2005) provided to customer with bathtub (serial number: (b)(4)), gas strut should be replaced every 3 years/36 months of usage.Based on quoted requirement we are able to state that preventive maintenance of the device was followed as the gas strut was replaced 2 years ago.Please notice that because the defective door gas strut was not returned for manufacturer's evaluation it was not possible to establish exact cause of malfunction.According to operating and product care instructions (opci; 04.Al.00/3 dated on november 2005) each user of the arjohuntleigh equipment should follow instructions from the booklet.In connection with the subject of this investigation, the following warnings were included to prevent from any injury occurrence (page 5): "always ensure that the equipment is handled by trained staff." "always ensure that the bathers limbs are clear of the door before closing." "always keep fingers clear of the door when closing." moreover, the opci recommends the user to check door operation on a weekly basis as per maintenance schedule (page 20).The opci also provides user with proper door usage instructions that should be followed to avoid malfunction and event occurrence: "never recline the bath unless the door is in the closed position." "always fit leg rest on opposite side of bath to door.If hung on the door - damage to the door will occur." this complaint was decided to be reported due to potential of injury if malfunction recurs and because the circumstances of failure detection were unknown.In conclusion, the product failure occurred and the device did not meet manufacturer specification.It was unknown if the bathtub was used for patient hygiene at the time of event and therefore unknown if it was directly involved in the event.We report this incident because of significant potential of injury if it was to recur and due to lack of information when the defect was detected.

• Brand Name: PARKER
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 7081990
• MDR Text Key: 94675072
• Report Number: 3007420694-2017-00222
• 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
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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: 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: 12/20/2017
• Distributor Facility Aware Date: 11/10/2017
• Device Age: 11 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/20/2017
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2006
• 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