MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z.O.O. ENTERPRISE 9000; FNL

Model Number 9X22BL101BFABA

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2015

Event Type  malfunction  

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.

Event Description

Initially, it has been claimed by the facility that one of the device's actuator was defective.Upon arjohuntleigh technician visit it turned out that the bed collapsed.It has been clarified that the event took place during nursing the patient at night.When the caregiver wanted to raise the bed, the radius arm detached from the spigots on the sub frame.The device was taken out of service.Fortunately there were no personal injuries.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for enterprise bed range (including model 5000x, 8000x and 9000x), we have found five cases with a similar fault description compared to the one investigated here: bed collapsed.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 of the device, it has been noticed that the gap between the end of the lift arm tubes and the retaining clip was approximately 8mm - exceeding the acceptable value for a correctly functioning unit.The size of the gap, was established to be related with the distortion visible in the seat section of the bed - surface of the seat section was dipping down toward the head end of the bed by approximately 20mm, thus increasing the gap.Significant damage was also noticed on the safety side on the patient's left hand side at the head end - a fairly deep indentation was present on the top corner of the safety side moulding.It has been concluded that the device involved in the event must have been an object of misuse - the bed has been continuously raised up against a solid obstruction - since the backrest actuator is mounted via a bracket onto the seat section, any extreme downward force on the backrest will cause the seat section to distort in the manner evident on this bed.The patient's left hand safety side is seems to be the place where the contact occurred between the bed and another object - as a result on the top corner of the side panel mounding there is a visible indentation.The design of the bed's electrical system is that if there would be an overload on any of the actuator (e.G.It would be trapped under a solid obstruction), it would not run further until the overload would be removed.Therefore the kind of damaged observed on the inspected device seems to be a result of the re-pressing the button on the handcontrol to re-initiate the movement, which lead later to the detachment of the radius arm and collapse of the bed.In accordance to the product instructions for use (e.G.#746-591_3), which are supplied together with each enterprise 9000x, the user of the device is warn to make sure that there is no obstacles such as a bedside furniture should restrict the bed movements, when it is operated.Therefore it is recommended to share with the customer conclusion of the conducted investigation paying attention to the correct use of the bed and avoiding contact with obstacles.In summary, the device was being used at the time of event for patient treatment.It failed to meet its specifications (bed collapsed so did not perform as intended), fortunately, there were no injuries sustained.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 9000
• Type of Device: FNL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5252403
• MDR Text Key: 32212043
• Report Number: 3007420694-2015-00218
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/15/2015,10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9X22BL101BFABA
• 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: 12/15/2015
• Distributor Facility Aware Date: 10/30/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2014
• 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