MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-23 for FREEDOM BATH AF14104US10 manufactured by Arjo Hospital Equipment Ab.
[58143061]
(b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[58143062]
Arjohuntleigh has received customer complaint where it was indicated that the freedom bath might not been properly secured to the floor. Additional information provided in service record by the service technician: "it was and shall be noted that this medical bathing system is not properly secured to the floor, as the manufactures mounting hardware has not been installed. The customer has been informed of the issues with this medical bathing system and should not be used until the above issues are corrected".
Patient Sequence No: 1, Text Type: D, B5
[63665461]
This report is being filed under exemption (b)(4) by arjohuntleigh (b)(4) (registration#(b)(4)) on behalf of the importer (b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for freedom bath we have found a low number of other similar cases where the mounting rails were not attached to the floor. There is very low complaint ratio for this kind of events in last 5 years. Arjohuntleigh received a service call to inspect installation issues. During the visit at the customer site, the technician found out that the facility supplied power cord was interfering with the lift accessible functions and the bath was not properly attached to the floor. Instruction for use (ifu, document number 04. Af. 02/9gb dated on 2012-06-01), which is delivered with every device, gives clear instructions regarding patient's safety. "a service routine must be performed on your freedom bath every year by arjohuntleigh authorized service personnel to ensure the safety and operating procedures of your product". "actions before the first use: : make sure that the bath has been installed according to the assembly and installation instructions". Detailed description of the installation process one can find in the attached assembly and installation instructions. There is installation kit, including mounting rails, which need to be securely assembled to the floor. When this step is completed, the bath should be placed on these rails, which prevent instability. This attachment should be checked every year during preventive maintenance. "warning to avoid injury and/or unsafe product, the maintenance activities must be carried out at the correct frequency by qualified personnel using correct tools, parts and knowledge of procedure. Qualified personnel must have documented training in maintenance of this device. [... ] check mechanical attachments - every year". This bath was never checked by any arjohuntleigh technician before and there is no information if the preventive maintenance has ever been performed. During the investigation it was found that the bath was most likely transferred from its original location (senior care center) to the actual customer (nursing home (b)(6), without any knowledge of arjohuntleigh representative. The bath was installed by a third party, and mandatory installation kit was not used. Neglecting of the proper attachment of the bath can be considered as unauthorized modification. As per ifu: "unauthorized modifications on any arjohuntleigh equipment may affect its safety. Arjohuntleigh will not be held responsible for any accidents, incidents or lack of performance that occur as a result of any unauthorized modification to its products". Installation kit, which was not mounted to the floor, can be ordered by the customer separately as a spare part under number afa0110. From above we can conclude that this problem was most likely caused by user error - user did not follow installation and maintenance requirements as per device labeling. The bath was not up to manufacturer's specification and it is unknown if it was used with the patients. This issue was reported in abundance of caution due to increased risk of the device tipping. There is no indication of any incident or adverse event. Please note that if every point from instruction for use and assembly and installation instructions was followed, there would be no patient or caregiver at risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00223 |
| MDR Report Key | 6049593 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-23 |
| Date of Report | 2016-08-24 |
| Date Facility Aware | 2016-08-24 |
| Report Date | 2017-01-20 |
| Date Reported to FDA | 2017-01-20 |
| Date Reported to Mfgr | 2017-01-20 |
| Date Mfgr Received | 2016-11-21 |
| Device Manufacturer Date | 2012-06-19 |
| Date Added to Maude | 2016-10-23 |
| 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 | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, TX 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM BATH |
| Generic Name | BATH, SITZ, POWERED |
| Product Code | ILM |
| Date Received | 2016-10-23 |
| Model Number | AF14104US10 |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-23 |