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

Model Number AK63611-US

Device Problem Device Tipped Over (2589)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The arjohuntleigh century bath is intended for assisted bathing and showering of adult residents in hospital and care facilities.The century bath must be used by appropriately trained caregivers with adequate knowledge of the care environment, its common practices and procedures, and in accordance with the guidelines in product's instructions for use.Arjohuntleigh received customer complaint where it was reported that century bath was tipping over causing fall of the resident and caregiver to the floor.Based on the event description, before fall, when the bathtub had been emptied of water resident was standing at the end of the bathtub and was holding the edge for support while staff was drying him off.According to additional information provided, both resident and caregiver did not receive any injury due to event, therefore hospitalization was not needed.Please note that situation occurred in this case was a direct result of not following the operating and product care instructions specified for this equipment.The century operating and product care instructions booklet [04.Ak.02_3usca issued in january 2007], which was delivered to customer with the device includes the safety instructions and warnings mitigating the risk: "do not allow the resident or operator to sit on the end of the bath tub." (o&pci, p.5) "do not allow anybody to stand in the bathtub." (o&pci, p.5) "always make sure that: the resident is sitting firmly, securely and in direction to face the panel to avoid injuries." (o&pci, p.4) after the event, the device was examined by arjohuntleigh representative and no malfunction of the evaluated device was identified.The device condition was found to be unlikely to cause or contribute to the reported symptom: tilt of the bathtub.As an immediate action, the bathtub has been secured to the floor with additional fixtures.It was not performed during installation of the device at the customer's site in 2007 as it was not obligatory and decision was based on the existing conditions in the facility.Therefore, this correction action was performed to diminish the possibility of event reoccurrence (affect stability of the bathtub) in case of using the device against warning indicated in the product instruction for use.The assembly and installation manual for century [04.Ak.02/3us,ca issued in october 2005] states: "caution! it is strongly recommended to fix the rear feet to the floor with four adaptive bolts." [p.9] moreover, the compliance of the bath design with iec 606001-1:1998 +a1:1991+a2:1995 regarding stability in normal use was confirmed in external tests.In reference to the whole information presented above, it should be emphasized that this event would not have happened if customer was following the operating and product care instructions for the involved device, which specifies the correct usage, patient positioning and warns against actions (e.G.Standing in bathtub, overloading the end of the bath).Although no adverse event occurred the complaint was decided to be reportable in abundance of caution as fall from the device may contribute to patient or caregiver injury upon recurrence.Due to the conducted investigation and bath inspection done by the arjohuntleigh representative, we were able to determine that although no technical deficiency was found within the device, the bathtub was reported to tilt and from that perspective the bathtub failed to meet its manufacturer's specification.The most possible contributing factor to this event is a use error due to not following proper use and bathing procedures established in operating and product care instructions.Please note that if caregiver would have followed every guideline given in the instructions there would not have been any use risk.

Event Description

Arjohuntleigh received customer complaint where it was reported that century bath tipping causing fall of the resident and caregiver to the floor.Based on the provided information, neither patient nor caregiver received any injury.

• Brand Name: CENTURY
• 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: 6927956
• MDR Text Key: 89948296
• Report Number: 3007420694-2017-00202
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2017

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: AK63611-US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2017
• Distributor Facility Aware Date: 09/15/2017
• Device Age: 9 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/09/2017
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2007
• 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): Other