MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA ENTERPRISE 5000; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Human Factors Issue (2948)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 2017-sep-21 arjohuntleigh was notified about incident involving arjohuntleigh enterprise 5000 bed.The reported malfunction took place in (b)(6) hospital in (b)(6).In received complaint it was reported that one of two caregivers operating enterprise 5000 bed raised bed's platform without warning other caregiver about this action.As a result the caregiver being not aware of bed's movement injured her knee.Unfortunately, despite our best efforts, it was impossible to collect any further information concerning this incident (either on the sustained injury, circumstances of the event or an exact serial number of the involved medical device).As it remind unknown which bed was being used during the incident, the device concerned could not be inspected by arjohuntleigh service technician.In respect to this information, this may be a sign that we may end up with some questions unanswered.The event was decided to be reportable to the competent authority due to an injury to knee sustained by caregiver.Because of very limited information provided regarding severity of the injury, arjohuntleigh, taking a cautious approach, has decided to report this event in abundance of caution.A review of the reportable incidents registered within last 5 years was performed in regards to the enterprise range beds.We have not been able to find any complaint with the same effect: injury of caregiver's knee due to bed's movement triggered by other caregiver.There is no trend observed, incident described above seems to be an isolated occurrence to date.It needs to be pointed out that none of the information provided to date indicate arjohuntleigh device failure that could have directly caused or contributed to injury on condition that the bed was being used in accordance to the labeling and recognized best practices of patient handling.To ensure the safety of our products the instruction for use provided together with the involved device (764-445-uk-6.1) includes the following information: "when the bed is operated, make sure that obstacles such as bedside furniture do not restrict its movement".Furthermore, the document advises the users: once a year "carry out a full test of all electrical bed positioning functions (backrest, height, tilt, etc.)".It has been established that two caregivers were operating enterprise 5000 bed while the complaint issue occurred.Following the information reported, when one caregiver activated up-function (without giving a warning to the another caregiver), the bed started to move up and injured caregiver's knee.Looking at the above scenario it can be presumed that caregiver's knee leaned against bed frame and when the device moved the bed frame hit caregiver's knee causing injury.With very limited information collected upon the investigation, it can be assumed that an error of use of the device is the most probable cause of the incident.If the user had followed the device labeling and no obstacles would restrict the bed movement, the is no possibility the caregiver might be posed at any risk of harm.There was no information given if the device was being used for patient handling at the time of the event.Since the severity of the knee injury sustained by caregiver remind unknown this complaint was decided to be reported to the competent authorities in abundance of caution.There was no indication of any technical deficiency within the device and from that perspective we assume that the device was up to its manufacturer's specification at the time of the complaint occurrence.If any additional information becomes available, we will reassess the event at that time.

Event Description

On 2017-sep-21 arjohuntleigh was notified about an incident involving arjohuntleigh enterprise 5000 bed.The reported malfunction took place in (b)(6) hospital in (b)(6).In received complaint it was reported that one of two caregivers operating enterprise 5000 bed raised bed's platform without warning other caregiver about this action.As a result the caregiver being not aware of bed's movement injured her knee.

• Brand Name: ENTERPRISE 5000
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6916898
• MDR Text Key: 89864100
• Report Number: 3007420694-2017-00203
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2017
• Distributor Facility Aware Date: 09/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2017
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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