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

Model Number CDB8051-01

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Injury (2348)

Event Date 06/17/2015

Event Type  Injury  

Event Description

It was reported by the customer that during the transfer of the resident on the alenti chair from room to the bath, the chair separated from the device column and the patient and the chair fall over the device.The caregiver due to the incident received knee trauma and was put for the 3 days rest.No injury caused for the patient.

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during the transfer from room to bath, the patient and the chair fell over the caregiver due to the breakage of the part linking the chair to the steering column.No injury caused for the patient.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of its specification.We do not appear to have any other complaint with similar failure.It is considered as an isolated case.The received serial number showed that device was being used by 13 years what is 3 years outside its operational life time, and this way the device could contribute to the event.Instruction for use - ifu (operating and daily maintenance instruction 04.Cd.02/6 gb from april 2000) active at the time of the manufacturing.Is provided with each device.It includes information about safe and correct use of the product.It informs in foreword: "the useful life of this equipment, unless otherwise stated is ten (10) years, subject to preventative maintenance being carried out in accordance with the instructions for care and maintenance." ifu provides also safety instructions: "warning: do not overload the lift hygiene chair! it has a lifting capacity of 160kg." "warning! don't overload the scale.Remove the load immediately, when the max-symbol is on." despite many requests for return neither parts nor the device was returned to the manufacturer for further evaluation.Parts could not be evaluated by the manufacturer and no conclusions could be made.Therefore, the exact root cause of the breakage could not be established.The photographic evidence was provided which confirms reported detachment.From the pictures we can only suspect that the reason for the load cell breakage is overloading and lack of proper maintenance.From above findings and fact that we do not appear to have any similar complaints we conclude that this incident was caused by user error - e.G.: using the device after recommended operational lifetime.The received information and our evaluation as described above are showing that if alenti's safety instructions were followed in accordance to ifu, there would be no user at risk.

• Brand Name: ALENTI
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan ; PL
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 62052 ; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4922272
• MDR Text Key: 6027744
• Report Number: 3007420694-2015-00135
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/14/2015,06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDB8051-01
• 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: 07/14/2015
• Distributor Facility Aware Date: 06/17/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/14/2015
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 76