MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-07-11 for SYSTEM 2000 AP31101-US manufactured by Arjo Hospital Equipment Ab.
[80034889]
(b)(4). Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4). As of 2014 that number was de-activated due to the site no longer 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 (b)(4). Arjohuntleigh was made aware about an incident that occurred in (b)(6). It was indicated that during cleaning the bathtub, the disinfectant has sprayed into the caregiver's face. The eyes were flushed with water immediately and then emergency room was visited. Fortunately, no injury was sustained. The device was examined by an arjohuntleigh representative after the incident. A hole in the disinfectant hose was found when the disinfectant was turned on. The bath was under arjohuntleigh service contract. The last maintenance was performed in july 2016, the service agreement was pending for renewal at the time of the incident. Claimed bath was identified as system 2000 with model number ap31101-us (primo) and serial number (b)(4). It was manufactured and tested in 2000 in (b)(4) in (b)(4). It was about 17 years old at the time of the incident. The bath was used with disinfectant cleanser iv, which is in line with arjohuntleigh requirements. When reviewing similar reportable events, we have found a low number of cases that may relate to the issue investigated here: diluted disinfectant splashed into the eyes, when the personal protective equipment was not used. Although there had never been reported serious injury in relation to similar inadequate sequence of actions taken by the caregiver, splashing the disinfectant solution onto the eyes, in combination with not using protective equipment (gloves, protective spectacles, as per instruction for use warnings), poses a potential risk of injury for the user, therefore this complaint was decided to be reportable in abundance of caution. Disinfectant cleanser iv is a fifth generation quaternary ammonium compound disinfectant cleanser. It is highly effective against a wide range of bacteria, viruses and fungi, yet is gentle for use on metals, plastics, rubber and fiberglass and gel coat finishes. System 2000 bath is intended for bathing and showering hospital or care facility residents under the supervision of trained skilled nursing staff in accordance with the instructions outlined in the operating and daily maintenance instructions. The device needs to be properly disinfected after each bath. It is equipped with a disinfection system, which allows for dosing a proper concentration of the disinfectant and flushing the bathtub with a special handle. In accordance to operating and daily maintenance instructions (document number 04. Ar. 10/1 ca dated on november 1999), provided with each device, certain personal protective equipment shall be used during that procedure: "always make sure that your skin and eyes are protected against concentrated disinfectant/cleaner. Carefully follow the instructions on the disinfectant/cleaner bottle! " "warning: always use protective gloves and protective eye wear when dealing with concentrated disinfectant. Avoid getting it on your skin or in your eyes. If contact occurs, rinse with copious amounts of water. If skin or eyes become irritated, consult a physician. " additionally, the disinfectant label provides precautionary statements: "danger: corrosive to eyes. Do not get in eyes, on skin or on clothing. " "first-aid: in case of contact, immediately flush eyes or skin with plenty of water for at least 15 minutes. For eyes, call a physician. " in this particular complaint, the involved caregiver was not wearing protective goggles, despite fact that they were available in the room, which represent using the product in a manner inconsistent with the bath and disinfectant labeling. What is more, age of the device seems to be a relevant factor when considering normal wear of the device and the incident occurrence. The bathtub in question was manufactured in 2000 and it was 17 years old at the time of the incident, therefore the maintenance procedures should be carried out thoroughly. Despite fact that this device was serviced by arjohuntleigh representative a year before incident, according to the operating and product care instructions, the caregiver's obligation was to check inter alia hoses between service intervals: "every week: examine the bath for cracks or other damage. Check for leakage. " from our evaluation we consider this event is the result of handling cleaning and disinfecting agent against the product labeling (the user was not wearing personal protective equipment at the time of event occurrence). The received information and our evaluation as described above are showing that if instructions concerning product using were followed in accordance to the labeling, there would be no patient or caregiver at risk. In summary, the device was not up to manufacturer's specification during the event occurrence - there was a hole in a disinfectant hose. The bath tub was not used for patient hygiene at the time of the incident, but it was prepared for use and in that way it played a role in this event. No adverse event (death nor serious injury) occurred.
Patient Sequence No: 1, Text Type: N, H10
[80034890]
Arjohuntleigh received information about an incident that occurred in (b)(6). It was indicated that during cleaning the bathtub, the disinfectant has sprayed into the caregiver's face. The eyes were flushed with water and emergency room was visited; fortunately, no injury was sustained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00155 |
| MDR Report Key | 6700203 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-07-11 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-06-13 |
| Date Facility Aware | 2017-06-13 |
| Report Date | 2017-07-11 |
| Date Reported to FDA | 2017-07-11 |
| Date Reported to Mfgr | 2017-07-11 |
| Date Mfgr Received | 2017-06-13 |
| Device Manufacturer Date | 2000-07-01 |
| Date Added to Maude | 2017-07-11 |
| 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 | 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | 24121, SW |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121, SW |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 2000 |
| Generic Name | BATH, SITZ, POWERED |
| Product Code | ILM |
| Date Received | 2017-07-11 |
| Model Number | AP31101-US |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 17 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 | 2017-07-11 |