MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. ENTERPRISE 9000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Physical Entrapment (2327)

Event Date 02/26/2014

Event Type  malfunction  

Event Description

Reference importer report number: (b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for enterprise(b)(4) devices, we have not found any case with similar fault description compared to the one investigated here: entrapment of a foot between lowered safety side panels and the floor.There is no trend observed for a reportable complaints with this fault description.Taking into consideration that over (b)(4) enterprise beds with split safety side panels have been sold since 2006, the complaint ratio is considered to be low- the failure rate for this event is (b)(4) against the installed base.The product involved in the incident is an enterprise (b)(4), serial number (b)(4) which was manufactured on 11-jan-2013.The device history record has been reviewed; no anomalies were recorded at the time of manufacture.Based on provided info it has been determined that the event occurred during the manual transfer of the pt from the bed to a chair.The bed's safety side panels were in lowered position.The exact height of the bed, defining directly the distance between the bottom of the side panel and floor, where the patient foot trapped, is unfortunately and despite our best efforts unk.Nevertheless, the bed's height has been defined as low- the worst case scenario, the bed could be in the extra-low position, when the under bed clearance is less than 120mm.The extra low height function reduces the risk of injury to patients if he/she was to fall out of bed.In the incident reported to us, it was indicated that the pt foot became trapped, and as the functionality of the bed was blocked with an alarm the caregivers lifted the bed in order to free the pt- unfortunately, there is no info which alarm blocked the bed functionality.The device involved in the event has installed 3 types of alarms: anti-entrapment system which is alarming if there is an obstacle between the base and top frame- the downward movement of the mattress platform is prevented until the obstruction is removed.This alarm is not affecting the raising function of the bed.Battery operation- occurs when a battery is at low charge, the continuous warning tone sounds when operating the bed- none of the bed's functions is blocked.Egress detection- is the system which alarms the caregiver in case when the pt has left the bed- this alarm is not causing locking of any function of the bed.Inspection device, has not confirmed any malfunction of mentioned above alarms or any other system failure within the bed.From our review, it seems to be likely, that in an emergency/stressful situation the caregiver has not used the bed's raising function correctly, or that the handcontrol has been locked and the caregiver might forget to unlock it in order to lift the bed platform and therefore in spite of pushing the up button on the handcontrol, the bed has not moved in required direction.In summary, the caregiver was manually lifting the (b)(6) person from the bed to the chair- it is the most probable during this operation, the patient's foot was placed between safety side and the floor, becoming trapped (possibly under some angle) during the further the transfer operation.Unfortunately, as the detail of how the transfer was conducted and what was the position of the pt are unk, further eval or recreation of the event is not possible.After the pt entrapment, the caregiver lifted the bed in order to move the pt, by doing it she suffered back injury.In accordance to a safety guidance, the maximum safe weight limit for use in patient-handling tasks should not exceed 35 pounds (16kg).When weight to be lifted exceeds this limit, an assistive device should be used.These limitations are necessary because of the safety of both caregiver and pt, who can be unpredictable or who can move during a lift, creating loads for the person doing the lifting.As the caregiver involved in the event was lifting firstly the pt weighing (b)(6) than additionally the bed with weight of approx.(b)(4), back injury occurred as possible consequence.In conclusion, the device was inspected by an arjohuntleigh rep at the customer site and was found to be to specification, the device was being used when the event occurred as the pt was transferred manually from the bed to the chair, the device contributed to the event since the patient foot became trapped between the bottom of lowered safety side and the floor and since the caregiver suffered a back injury while trying to lift the bed to remove patient after entrapment.Given the circumstances and the number of products in the market this incident appears to be a remote issue.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: ENTERPRISE 9000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 0000 ; PL 0000
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 0000 ; PL 0000
• Manufacturer Contact: pamela wright ; 12625 wetmore; san antonio, TX 78247-0000 ; 2102787040
• MDR Report Key: 3773666
• MDR Text Key: 14875912
• Report Number: 3007420694-2014-00037
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2014
• Distributor Facility Aware Date: 03/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2014
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 90