MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. TENOR

Model Number KHA1000-US

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589); Device Handling Problem (3265)

Patient Problems Contusion (1787); Pain (1994)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a use error the device did not perform as intended.Additional information will be provided following the conclusion of the investigation.

Event Description

Arjohuntleigh has received a customer complaint where it was indicated that at the time of positioning the patient onto a bed, using tenor standing hoist, the lift tilted sideways.Following the information reported, one caregivers was trying to slide the patient upward towards the head of the bed by grabbing the sling whereas another caregiver was trying to move the lift with the resident's body weight already positioned on the bed.As a consequence of this incorrect device handling, the device was reported to lose its stability and tilted towards the right and jerked back down towards the left landing on the caregiver's foot the caregiver has sustained a contusion on top of the right food.

Manufacturer Narrative

When reviewing similar reportable events, we have found a number of cases that may relate to the issue investigated here: tenor lift tilted sideways during the resident transfer.We have been able to establish that compared to the amount of sold devices and in comparison to their daily use the occurrence rate of reportable complaints with this failure is relatively low.It is worth noting that the tenor hoist has been designed, produced and certified to meet the requirements of the iso (b)(4) stability test.It has been proven 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.In this particular case, to bring the patient over the upper part of the bed, one of the involved caregiver had decided to pull the patient into desired place by pulling the sling, another caregiver was trying to move the tenor device.In respect to this information, it appears more likely that the person in the sling was being vehemently pulled into the desired position and the lift destabilized in the direction that was pulled.This incorrect way of positioning the resident caused that the hanger bar was outside the center of the gravity.This constitutes a use error: not placing the lift as described in the instructions for use (ifu), not avoiding the use of the body of the patient as leverage.Our evaluation appears to suggest a use error having occurred.In the labelling there is a particular attention to the responsibility of the device owner to make sure that the device users are trained and knowledgeable of the contents of the labelling and correct procedure for lowering the resident.When the ifu would have been followed the event would have been avoided.The post incident re-training has been already provided to the involved caregiver staff.To sum up, the device was being used at the time of the event and played a role due to a use error - causing the device to not perform to the specification.The device was up to the manufacturer specification at the time of the incident.This complaint decided to be reportable in abundance of caution as there is a potential that similar sequence of actions taken by the caregivers can result in serious injury.

• Brand Name: TENOR
• Type of Device: TENOR
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. piotra wawrzynika 2; komorniki, 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. piotra wawrzynika 2; komorniki, 62052 ; PL 62052
• Manufacturer Contact: mike mcandrew ; 2349 west lake st.; addison, IL 60101 ; 6303293401
• MDR Report Key: 5909280
• MDR Text Key: 54157498
• Report Number: 3007420694-2016-00184
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Caregivers
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/30/2016,07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: KHA1000-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Distributor Facility Aware Date: 07/29/2016
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2013
• 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 Weight: 249