MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-09 for CENTURY AK63611-US manufactured by Arjo Hospital Equipment Ab.
[89948296]
(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.
Patient Sequence No: 1, Text Type: N, H10
[89948297]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00202 |
| MDR Report Key | 6927956 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-09 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-09-13 |
| Date Facility Aware | 2017-09-15 |
| Report Date | 2017-10-09 |
| Date Reported to FDA | 2017-10-09 |
| Date Reported to Mfgr | 2017-10-09 |
| Date Mfgr Received | 2017-09-15 |
| Device Manufacturer Date | 2007-12-17 |
| Date Added to Maude | 2017-10-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KINGA STOLINSKA |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121, SW |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121, SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURY |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2017-10-09 |
| Model Number | AK63611-US |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121, SW SW 24121, SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-09 |