MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. MINSTREL (INCL. MINERVA); NONE

Model Number TME.100

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Arjohuntleigh has become aware of the issue where on unknown date, during the patient transfer, the device fall sideways.It was stated that the device: minerva lift became unstable due to broken element of the chassis assembly: tie rod.At the time of the issue, the caregiver was able to put the patient safely down, laying him on a small table.No injuries occurred.

Manufacturer Narrative

(b)(4).An investigation was performed on this complaint.When the event occurred, the device was used for treatment of a person, it played a role in the event and was found not to be to specification when the event occurred.Based on the description of the event, during the time of the event the caregiver was able to put the patient safely down, laying him on a small table.As a consequence no injuries were reported.When reviewing similar reportable events for minerva (and the similar): minstrel devices, we have found four cases that may relate to the issue investigated here: malfunction of the spreading mechanism during use.We have been able to establish that compared to the amount of sold devices and in comparison to their daily use the occurrence rate observed for reportable complaints with this failure is very low.The device produced in the belgian arjohuntleigh production facility, now closed.The device investigated here has reached its intended and labeled lifetime of ten years in oct 2011.This means the device was used over 3 years beyond it's intended lifetime.There appear to have been no complaints on this device since the device was delivered to the customer, up until the event took place.Moreover our investigation reveals that the device was not under arjohuntleigh service or preventive maintenance and was not regularly serviced.(b)(4).Based on the collected information, the conclusions from internal investigation test performed by the previous ((b)(4)) manufacturer's technical department and findings made during the inspection of the complaint device, we (arjohuntleigh) have been able to establish that the chassis mechanism failed to remain structurally conform, possibly due to all the stress it may encounter during its lifetime.It also has been concluded that there does not appear to be any reason for concern of the safety of the person in the lift, or the operator, as a direct result of a tie-bar breakage.The failure of the device is apparent to the clinical staff, the user is not likely to continue to use of the device after detecting it, minimizing the possibility that this could further lead to the hazardous situation.There is no direct risk for the patient or the caregiver as a direct result of a tie bar breakage - because of the presence of a built-in secondary safety feature - as long as there is no additional factors leading to hazardous situation.In the investigated situation, it seems that a human error could play a significant role and lead to the hazardous situation.Structure of the foot pedal mechanism is subject to wear and must be restored or replaced when factors are not working.Arjohuntleigh devices that have specified in their labeling that their intended lifetime is ten years if and when they are correctly serviced, are designed and were verified and validated to be able to achieve this period.However when the device is used beyond this period and in addition not used and maintained correctly, the device can fail.

• Brand Name: MINSTREL (INCL. MINERVA)
• Type of Device: NONE
• 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 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4862291
• MDR Text Key: 18294919
• Report Number: 3007420694-2015-00122
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/19/2015,05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TME.100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2015
• Distributor Facility Aware Date: 05/26/2015
• Device Age: 14 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/19/2015
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2001
• 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