MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. TENOR; NONE

Model Number KHA1010

Device Problem Device Tipped Over (2589)

Patient Problem Contusion (1787)

Event Type  malfunction  

Event Description

Arjohuntleigh received a complaint where it was indicated that during the resident transfer to the wheelchair the tenor lift tipped over sideways and fell on the caregiver.The lift hit the caregiver in the shin causing a contusion.The patient was not injured.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events, we have found a number of cases with similar fault description (tilted sideways).The trend observed for reportable complaints with this failure mode is currently considered to be low and stable.It has been established that the lift device (tenor) was being used for patient handling at the time of the event.No malfunction could be found on the tenor lift that could have caused or contributed to the event.In this case we can determine that the tenor and the sling which work as a system were found to have been to specification when the event took place.From the information received it appears that during transfer of the patient to the wheelchair the tenor lift tipped over sideways and fell to the floor.Our lift devices fulfill the iso requirements of being stable with the safe working load weight in the most adverse position.As required per iso 0535 a stability test has been performed that proves that even on a tilting slope, when lifting 1.25x the safe working load, and in the most adverse position, the tenor does not become unstable.Based on the event description, pictures from the facility, review of previous related complaint investigations and the technician conclusions, it appears the tenor was not correctly positioned above the wheelchair.This would mean that the hanger bar was not positioned over the center of the chair seat.What is more, looking at the pictures from the reconstruction of the event, the tenor was not positioned towards the wheelchair with the legs under or around the wheelchair, but tenor was put aside.In such a situation, to bring the patient over the center of the seat, the caregiver may have decided to pull the patient into place which can destabilize the lift.It is also possible that the person in the sling was vehemently pulled into the desired position and the lift toppled over in the direction that was pulled.This constitutes a use error: not placing the lift as described in the ifu, not avoiding the use of the body of the patient as leverage.The possible sequences of event presented above seems to be the most probable and to be in line with the event description our evaluation appears to be in line with a use error having occurred.In the labeling there is particular attention to the responsibility of the device owner to make sure that the device users are trained and knowledgable of the contents of the labeling.When the ifu and the correct lifting procedure would have been followed the event would have been avoided.From this evaluation it would appear most likely that the event was caused by the user not following the ifu, due to lack of awareness of the ifu contents.Only as a result of this did the device contribute to the outcome of the event.We find this complaint to be reportable to the competent authorities.(b)(4).

• Brand Name: TENOR
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4418533
• MDR Text Key: 19307583
• Report Number: 3007420694-2014-00142
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/22/2014,11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KHA1010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2014
• Distributor Facility Aware Date: 11/24/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/22/2014
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 168