MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-06-15 for MALIBU AJL13341-GB manufactured by Arjohuntleigh Polska Sp. Z O.o..
[47396352]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for malibu we have found other similar cases where the chair did not securely attach to the lifting arm. We have been able to establish that there is no complaint trend concerning these kinds of events. The patient was being transferred to the bathroom using a bath chair and a transfer trolley. After being cleaned up post commode the seat was moved into position to begin lift into bath. The hand control was used to raise the chair. On attempting to remove the transfer trolley, the patient and the chair frame fell to the floor and in that way contributed to the event. No injury occurred. The device has been tested by technician - function test showed that the device was working to its specification. No repair or adjustment has been done. An arjohuntleigh technician tested bath function focusing on transfer procedure. The seat has been moved up to lift arm using hand control. The handset was used to raise chair frame until the latch was correctly located. The transfer trolley was removed and transfer into the bath- test was completed without problems (test was performed with and without load). No malfunctions were found that could have caused or contributed to the event. The product's instruction for use is attached with each device, ifu includes information how to properly and safely use the device: "always make sure that: all lifting/transporting equipment is in good condition, follow the instructions for all equipment; chair seats, shower tables etc. , are fastened and all screws tightened; the wheels always are locked during resident handling, except during transportation". The instruction for use also includes warnings concerning the locking mechanism of the lifting unit and seat and transferring chair: "before using the transfer chair, make sure it is safely attached to the lift arm and that the locking mechanism is thoroughly locked. "; "when using the lift arm with transfer chair and/or using the height adjustable bathtub, the operator must assure that there are no obstructions or persons in the immediate vicinity that could impede its movement. ". Moreover the ifu provides instructions how to properly connect chair to the lifting unit: "connecting: set the bath tub in its lowest position by press and hold the lowering of tub button; press lift out of tub; grip the transfer chair and place the attachment of the chair and hook up the chair to the lift arm; raise the lift arm by press the hold the lift into tub button, do that the transfer chair is hooked up on the lift arm and the chassis gets clear of the floor; make sure that hooks (a) are securely attached to the lift arm and that the safety catch (b) is in place. Also the ifu contains the warning: "before transporting residents on the transfer chair with chassis always make sure that the transfer chair is safely attached to the chassis i. E. That the spring loaded catch has clicked into its locked position. " information provided in the complaint indicates that the chair failed to be securely attached onto the lifting arm hook. The bath and transfer trolley have been tested and no failure was found. There was no possibility to recreate the event. The bath was in good working condition. According to the above the bath was found to have been to specification when the event took a place. It can be established that bath was being used for patient handling but it appears it contributed to the event likely due to a use error. Please note, that if the caregiver follows every guideline given in instruction for use, there is a really low possibility of any potentially risky situation to occur.
Patient Sequence No: 1, Text Type: N, H10
[47396353]
There was initially reported to arjohuntleigh representative that:. "patient was being transfer to bathroom using bath chair and transfer trolley. After being cleaned up post commode the seat was moved into position to begin lift into bath. The hand control was used to raise the chair. On attempting to remove the transfer trolley, the patient and the chair frame fell to the floor. No severe injuries reported. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2016-00112 |
| MDR Report Key | 5725423 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-15 |
| Date of Report | 2016-05-17 |
| Date of Event | 2016-05-16 |
| Date Facility Aware | 2016-05-17 |
| Report Date | 2016-06-15 |
| Date Reported to FDA | 2016-06-15 |
| Date Reported to Mfgr | 2016-06-15 |
| Date Mfgr Received | 2016-05-17 |
| Device Manufacturer Date | 2007-09-03 |
| Date Added to Maude | 2016-06-15 |
| 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 | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALIBU |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-06-15 |
| Model Number | AJL13341-GB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-06-15 |