MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. ENTERPRISE 8000

Model Number ENT8000

Device Problems Collapse (1099); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

Initially, it has been claimed by the customer that the bed's "hydraulics have come out of the socket".Inspection of the device revealed that the bed had collapsed - the radius arm has detached from the sub frame and fell on the floor.The device was found in this condition in a corridor by onsite facilities members.It had been previously in use within the ward, under a patient.The customer site, unfortunately, cannot provide an accurate date as to when they were first notified by the ward of the beds failure.Specific details of event as well as the circumstances under which the failure occurred have been not determined as the event was not witnessed by anyone, it would appear.

Manufacturer Narrative

(b)(4).Investigation which includes an inspection of the bed is currently ongoing.Additional information will be provided upon conclusion of the investigation.(b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for enterprise bed range (including model 5000x, 8000x and 9000x), we have found three cases with a similar fault description compared to the one investigated here: bed collapsed.Unfortunately, without having detailed witness description of what occurred, we are left to review the information received from the customer per our best efforts, and compare it to our product knowledge that in part comes from previous complaint investigations.Based on the collected information, photographic evidence and findings made during the inspection of the bed conducted by an arjohuntleigh representative it has been established that the bed collapsed as the radius arm detached from the sub-frame.During the inspection it has been noticed that the stabilizer arm (which should be assembled from the one side to the radius arm and from the other to the base frame) was detached from the frame.The starlock that secures this connection was missing, however the pin on which the starlock should be assembled had marks indicating that the part originally had been installed.An attempt to recreate the event was made in order to check if a detached stabilizer arm has an influence on the device's stability.A bed from the factory assembly line without the stabilizer arm attached to the bed's base frame was raised and lowered with load of 75 kg.During this check the device was stable, no issue arose from the bed being used to height-adjust the "patient" without the stabilizer arm.It has been also noticed that if the stabilizer arm is detached, it is easy to detect, as the part touches the bed's frame or the floor during the device movement and as a result makes noise.Therefore it seems that the detached stabilizer arm did not have an influence on the bed's collapse.Additionally, during the device inspection it has been confirmed that the retaining clip was not present.Unfortunately, despite our best effort we are unable to establish if it went missing as a result of the radius arm collapse or it was the factor which contributed to the collapse.It is also worth noting that the enterprise 8000x bed has been designed, produced and certified to meet the requirements of standard en 60601 2 52.The enterprise 8000x beds are passing the requirements of clauses: 201.9.4.2.3 - instability from horizontal and vertical forces, 201.9.8.3.1.Installed swl, 201.9.8.3.2.Static forces due to loading from persons or 201.9.8.3.3.1 dynamic forces due to sitting down.This confirms that the beds are stable devices which are not falling apart during usage.Therefore we cannot see that this kind of failure occurring in normal use and feel that there must have been some additional factors, which have led to this situation.Unfortunately, we have been not able to determine the exact cause of the event.Additionally, as with all of our devices and their components care must be practiced so as to preserve the quality and life of the device and its components.Responsible care must be taken when using any part of a device that comes into contact with a patient or user.In accordance to the product instructions for use (eg #746 585_2), which are supplied together with each enterprise 8000x devices, maximum safe working load of the bed is 250 kg, while the maximum patient weight is 185 kg.Both values should not be exceeded.Also when the bed is operated, no obstacles such as a bedside furniture should restrict the bed movements.Nevertheless, the information about the event are very limited, therefore we are not in the position to assess if the customer has followed the recommendation from the product instruction for use regarding patient weight and use of the product.In summary, the device failed to meet its specifications (bed collapsed), fortunately, there were no injuries sustained.It is unknown if the device was used at the time of event as it was not witnessed.Given the circumstances 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 8000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan PL-62 052; PL PL-62052
• 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 ; 2102787040
• MDR Report Key: 4862276
• MDR Text Key: 5849155
• Report Number: 3007420694-2015-00121
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2015,04/08/2015

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: ENT8000
• 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: 04/08/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2015
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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