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 2019-01-10 for PARKER BATH AL14110-US manufactured by Arjo Hospital Equipment Ab.
[134493390]
(b)(4). The arjo qualified representative visited the customer facility due to the service request, which stated that the bath door is difficult to operate and lock. During the evaluation it was found that door gas strut is broken and the door latch is rusted out. The door gas strut was separated at the mounting point into two pieces and caused the door to falling heavily. No injuries were reported by the customer facility. It was not possible to confirm that the bathtub was removed from usage, when the malfunction was noticed. The door gas strut, latch and handle were replaced and disposed after the completed service. Please note that according to operating and product care instructions (ifu; 04. Al. 00_4 dated on april 2007) delivered with the device, each user of the arjo equipment should follow the instructions from the booklet. In section "care and maintenance" the device user is informed that door gas strut should be replaced every 3rd year. According to the performed review of the device's service history the gas strut was replaced by arjo qualified personnel in april 2014 so the part was in use for over 4 years before it failed. The claimed bathtub was not under the arjo service contract and repairs were conducted only upon the customer request. In connection with the subject of this investigation, the following warnings were included to prevent from any injury occurrence: "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. " the ifu 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. " the ifu also reminds the customer to check operation of the door regularly on a weekly basis to detect any failure related to this assembly. Based on the performed investigation the cause of this malfunction appears to be related to lack of proper maintenance. The review of reportable events with the involvement of the parker bath in last years revealed a limited number of similar complaints. In summary, according to the customer allegation, the door gas strut failed and led to door falling. It is unknown if the bathtub was used for a patient hygiene at the time of event. Based on the collected information about the malfunction the device was not up to the manufacturer's specification. This complaint was decided to be reported to the competent authorities in abundance of caution due to the information about malfunction (door falling), which could have led to the injury occurrence and lack of information indicating circumstances in which the malfunction was detected.
Patient Sequence No: 1, Text Type: N, H10
[134493391]
The arjo qualified representative visited the customer facility due to the service request, which stated that the bath door is difficult to operate and lock. During the evaluation it was found that door gas strut is broken and the door latch is rusted out. The door gas strut was separated at the mounting point into two pieces and caused the door to falling heavily. No injuries were reported by the customer facility. It was not possible to confirm that the bathtub was removed from usage, when the malfunction was noticed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00015 |
| MDR Report Key | 8235132 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-11-27 |
| Date Facility Aware | 2018-12-13 |
| Report Date | 2019-01-10 |
| Date Reported to FDA | 2019-01-10 |
| Date Reported to Mfgr | 2019-01-10 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2008-07-07 |
| Date Added to Maude | 2019-01-10 |
| 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, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| 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 | PARKER BATH |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2019-01-10 |
| Model Number | AL14110-US |
| Device Availability | Y |
| Device Age | 10 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 | 2019-01-10 |