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 2016-09-02 for PARKER BATH AL11012-EU manufactured by Arjo Hospital Equipment Ab.
[53798210]
(b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[53798211]
On (b)(4) 2016 arjohuntleigh received a customer complaint where it was indicated that the resident was scalded in bath. The thermometer of the water showed 63,4? C. On 24th august 2016, during interview with the user facility representative, additional information was provided. The bath was filled with water, the resident sat on the knees of the caregiver. When the resident's feet were put into the water, she cried out and was lifted out of the water. As a consequence of the event, the resident sustained scalding of second degree on the soles of both feet. Treatment was described as cleaning of wounds and skin transplantation. The resident spent about 2 weeks in hospital.
Patient Sequence No: 1, Text Type: D, B5
[57613873]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for parker bath we have found a low number of other similar cases where there was a risk to the patient because of too hot water. We have been able to establish that there is no complaint trend concerning this kind of event. Please note that arjohuntleigh manufactured about (b)(4) parker baths to date. Parker bath is a height adjustable bath system intended for assisted bathing. It is equipped with a thermostatic mixer that contains 3 temperature and pressure controlled cartridges. These cartridges are responsible for water temperature adjustment, and if these cartridges are damaged, inter alia by poor water quality, it is possible to get different water temperature than set. Instruction for use, which is provided with each device, contains information about safe and correct use of the product. "always check the water temperature prior to placing bather in the bath or using shower. " "check the temperature of the water by hand. " the product in this complaint is subject to wear and tear. To preserve its performance and safety, preventive maintenance is to be carried out - a list of recommended steps can be found in instruction for use. In accordance to ifu, apart from the fact that the thermostatic mixer should be checked every year by qualified personnel, the caregiver is obliged to perform checks every month. There is also the following warning: "warning: the points on this checklist are the minimum the manufacturer recommends. In some cases due to heavy use of the product and exposure to aggressive environment, more frequent inspections should be carried out. Continuing to use this product without conducting regular inspections or continuing to use this product when a fault is found will seriously compromise the user and residents safety. " from above, the root cause of this event appears to be a user error - not following warnings included in instruction for use concerning checking water temperature by hand and incorrect tub preparation for use by insufficient maintenance. This bath was out of the manufacturer's specification at the time of event. The device was being used for patient handling and in that way contributed to the event. The received information and our evaluation as described above shows that if all the warnings and recommendations were followed in accordance to instruction for use, there would be no patient or caregiver at risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00193 |
| MDR Report Key | 5924301 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-09-02 |
| Date of Report | 2016-08-04 |
| Date of Event | 2016-08-03 |
| Date Facility Aware | 2016-08-04 |
| Report Date | 2016-09-29 |
| Date Reported to FDA | 2016-09-29 |
| Date Reported to Mfgr | 2016-09-29 |
| Date Mfgr Received | 2016-08-04 |
| Device Manufacturer Date | 2009-12-17 |
| Date Added to Maude | 2016-09-02 |
| 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 | MRS. PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE, STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER BATH |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-09-02 |
| Model Number | AL11012-EU |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 7 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. Hospitalization | 2016-09-02 |