MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. ALENTI; FSA

Model Number CDB8153-01

Device Problems Partial Blockage (1065); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2015

Event Type  malfunction  

Event Description

It was reported that the user has lifted the resident on the alenti chair to transport him over the edge of the tub.Then tried to lower the resident into a tub but the lift would not go down.The user had other workers come and they manually assisted the resident into a wheelchair.The lift was brought to maintenance for repairs.There were no reported any injuries.

Manufacturer Narrative

(b)(4).Arjohuntleigh has received a complaint where it was indicated that during the procedure of lowering a person that was seated on the alenti shower chair, the device chair became stuck in the highest position with the patient on the seat.As the device could not be lowered and the patient was safely taken off the lift manually.Neither patient nor caregivers have suffered any injuries.When reviewing similar reportable events, we have found a number of cases with similar fault description (alenti stuck in highest position).With the amount of sold devices and with comparison to the daily use of them the complaint ratio ((b)(4)) observed for reportable complaints with this failure mode on alenti is considered to be low and stable.Please note that arjohuntleigh manufactured more than (b)(4) alenti devices to date.It has been established that the hygiene chair (alenti) was being used for patient handling at the time of the event.The lift was inspected by our representative that visited the customer site and was found to have not been to specification at the time of inspection.From our investigation, it appears the most likely root cause for an event was that the alenti actuator malfunctioned and became stuck in its highest position, as a result of certain use situations that can be seen as off-label.The failure found here is not likely to appear on every device: a convergence of situations needs to occur for the failure to manifest itself.Based on the findings of the investigation, a corrective action has been requested, currently the issue is ongoing.The complaint history review shows that there is a low likeliness of risk for the patient when the actuator becomes stuck.

• Brand Name: ALENTI
• Type of Device: FSA
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 0000 ; PL 0000
• Manufacturer Contact: pamela wright ; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4913232
• MDR Text Key: 20150207
• Report Number: 3007420694-2015-00132
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/10/2015,06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CDB8153-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2015
• Distributor Facility Aware Date: 06/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2015
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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: 86 YR
• Patient Weight: 54