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 2016-06-08 for MALIBU manufactured by Arjohuntleigh Polska Sp. Z O.o..
[46800222]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[46800223]
It was initially reported to arjohuntleigh representative that: "a client was being removed from the malibu bath and the operator had pressed the handset to raise the chair up and out when the chair swung out before clearing the bath fully, resulting in the clients genitals being caught between the chair and the bath. No injury occured. "
Patient Sequence No: 1, Text Type: D, B5
[49249569]
An investigation was carried out into this complaint. It can be established that the device was being used for the patient handling - hoisting patient from the bath, and in that way contributed to the event. The chair was not on the proper position while chair was rotating outside the bath. It was reported in complaint that the chair was rotating only 8 mm above the bath edge resulting in the clients genitals being caught between the chair and the bath. No injury occurred. All devices are equipped with instruction for use which clearly inform how to properly use and maintenance the device. Ifu for malibu (04. Aj. 00/2gb) from feb-2006 contains warnings: "make sure that the resident's hands and feet are placed on the appropriate resets. Failure to heed these safety precautions may result in injury to the persons involved or to the equipment". "make sure that the resident's hands and feet do not get trapped/squeezed between the seat and hump (malibu contour) in the final stage of lowering the seat into the tub". Also caregiver is obligate to perform preventive maintenance and once a week should test all panel function including lifting functions and check lifting arm for correct movement. The bath has been tested by technician. The device was out of specification at the time when the event occurred. No part has been replaced, the bath just needed to be reset. After this operation, the functionality test has been performed several times and chair operated properly each time. There are a few likely causes which might cause the failure with chair positioning (e. G. Additional magnetic field present while chair operation which might interrupt in proper device functioning, failure of device component responsible for chair localization), however neither of the above causes could be confirmed with certainty. Despite deep device evaluation and investigation of received data, the exact root cause of the device rotating too early could not be established. The situation where the chair was rotating 8 mm above the bath edge resulting in the clients genitals being caught between the chair and the bath are considered to be unfortunate accident. When reviewing similar reportable events on malibu bath, we have found one similar case. Please note that arjohuntleigh manufactured approximately 14000 malibu baths to date. With an amount of sold devices and to the comparison of a daily use, complaint rate for this failure mode is considered to be very low (0,01%). There are also other factors that need to appear to cause this incident e. G. : lack of carefulness, patient was not positioned properly on the chair. The device was being used for patient when the event took place and in that way contributed to the outcome of the event. The device was not according to specification when the event occurred, however the exact cause cannot be established. We continue to monitor the issue and provide additional information in case of new facts become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00103 |
| MDR Report Key | 5706102 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-05-07 |
| Date Facility Aware | 2016-05-12 |
| Report Date | 2016-07-08 |
| Date Reported to FDA | 2016-07-08 |
| Date Reported to Mfgr | 2016-06-08 |
| Date Mfgr Received | 2016-05-12 |
| Device Manufacturer Date | 2016-11-20 |
| Date Added to Maude | 2016-06-08 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALIBU |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-06-08 |
| Device Availability | Y |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-08 |