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 2017-09-26 for PARKER AL14110-CA manufactured by Arjo Hospital Equipment Ab.
[87761884]
(b)(4). Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment (b)(4) (under registration #(b)(4)). As of 2014 that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa. From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4). Parker bath is intended for assisted bathing and showering of adult residents in care facilities. It is equipped with a full-length side opening for easy access of mobile patients. The door can be opened by pulling the lever down and lifting the door up. The gas spring is adjusted to facilitate door opening and to keep the balance of the door in raised position, to avoid door falling. Arjohuntleigh received customer complaint where it was reported that parker bath door fell on the caregiver's left forearm. According to additional information provided caregiver received bruising on arm. There was no hospitalization needed. After the incident the device has been examined by arjohuntleigh representative who found that the end securing snap on pivot knuckle was separated from the strut. In addition, there was no connection between gas strut and door hinge which as a consequence caused that the door could not keep an upright position. As an immediate action, the involved bath system was excluded from further use till the service repair will be conducted. To ensure the safety of our products operating and daily maintenance instructions booklet, which is delivered with each device (document number (b)(4) dated on (b)(6) 2002) includes the following warnings: "please contact us [arjohuntleigh] if you have any questions about the operation to maintenance of your parker bath" (o&dm instructions, p. 3) "annually: a full service and safety check should be performed by our fully trained service engineers. " (o&dm instructions, p. 14) if any malfunction would be noticed during the check, the qualified personnel service needs to be called for repair. The device cannot be used till the repair is completed. Additionally, maintenance and repair manual [09. Al. 00_1gb dated on june 2003] provides preventive maintenance schedule for parker bath. The equipment is subject to wear and tear, and recommended maintenance instructions must be performed when specified to ensure that the equipment remains within its original manufacturing specification. List of recommended steps can be found in product instructions for use. In order to ensure the efficiency and functionality of the door strut, this particular component should be checked every 12 moths according the following instruction: "open the door and check that the gas strut holds the door in the upright position and does not drop. " it informs also that the door strut should be replaced after 48 months/4 years of functioning. According to the opinion given by arjohuntleigh field service technician, the involved gas strut was in use for about 13 years (since installation of the involved bathtub) and has never been replaced, which demonstrates that the recommendations presented in maintenance and repair manual were not followed. In summary, although no adverse event occurred the complaint was decided to be reportable in abundance of caution as the caregiver sustained bruising on arm as a consequence the door of the bath was not working as per manufacturer's specification (the gas strut component could not keep the door in the upright position). It remained unknown if the device was being used for patient treatment at the time of the incident. Upon the conducted investigation and bath inspection done by the arjohuntleigh representative, we were able to determine that the most possible contributing factor to this event is incorrectly performed procedure of the device inspection, as recommended in the preventive maintenance (gas strut was not replaced every 4 years). All the above, brought us to the conclusion that the failure to follow safety instructions and recommendations included in the device maintenance and repair manual might have been a primary cause of the event occurrence. If all the points of the instruction for use and maintenance and repair manual are followed, there would be not patient or caregiver at risk.
Patient Sequence No: 1, Text Type: N, H10
[87761885]
Arjohuntleigh received customer complaint where it was reported that parker bath door fell on the caregiver's left forearm. According to additional information provided, caregiver received bruising on forearm. Facility was not aware of any hospital visit by caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00198 |
| MDR Report Key | 6893393 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-09-26 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-08-30 |
| Date Facility Aware | 2017-08-30 |
| Report Date | 2017-09-26 |
| Date Reported to FDA | 2017-09-26 |
| Date Reported to Mfgr | 2017-09-26 |
| Date Mfgr Received | 2017-08-30 |
| Device Manufacturer Date | 2004-01-26 |
| Date Added to Maude | 2017-09-26 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2017-09-26 |
| Model Number | AL14110-CA |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 13 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 | 2017-09-26 |