MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA ENTERPRISE 8000; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(4) 2017 arjohuntleigh was notified about a complaint involving enterprise 8000 bed.The following information provided the nurse who came over to give treatment to the patient lying on the bed received an electric shock.The incident took place while her leg touched the metal bar at the side of the bed.In consequence, she sustained small burn to the leg.No other outcomes were reported.The nurse was not hospitalized, no medical intervention was required.When reviewing similar reportable events for enterprise 8000, 8000x, 9000, 9000x range of beds, we have been able to find very low number of other cases with similar fault descriptions compared to the situation investigated here: electric shock to the user.It needs to be emphasized that enterprise 8000 beds are conform with iec 60601-1 standard for medical devices and classified by (b)(4) in accordance with iec 60601-1 and iec 60601-2-38.The above confirms that the enterprise 8000 bed meets all standards and requirements for the safety of medical electrical equipment.Additionally, each bed needs to pass electrical test before being dispatched.Therefore we don't find bed's design and manufacturing process to be a case.The involved bed was examined by arjohuntleigh's representative after the reported event.The evaluation revealed that there was some damage to the paint work found, also the backrest actuator wobbled as it rose.Moreover the battery backup was missing and the mains lead was found to be defective (wires inside the mains lead were twisted and small crush point was detected on the insulation).Despite the above the overall condition of the bed was assessed as good.The engineer completed a full function test which revealed that there were no functionality discrepancies found within the device.Additionally to determine the root cause of reported incident the technician performed a portable appliance testing.Portable appliance testing (pat) is the term used to describe the examination of electrical appliances and equipment to ensure they are safe to use.However, it is essential to understand that visual examination is an essential part of the process because some types of electrical safety defect cannot be detected by testing alone.The device was pat tested in accordance to the requirements for double insulated devices.The device passed the test successfully.The bed in question was under arjohuntleigh service contract.Last preventive maintenance was performed on 2017- jul by arjohuntleigh representative to ensure the safety of our products the instruction for use provided together with the involved device (e.G.: 746-435-uk rev 8 from 2012-sep ) warns: "to avoid the risk of electric shock, this product must only be connected to an electricity supply with a protective earth".From the above evaluation we conclude that although the pat test was passed the bad condition of mains lead could contribute to the incident in this particular case.The mains cable malfunctions as such can appear while the cable is run over the bed or trapped by bed's components.The complaint was decided to be reportable due to the allegation of electric shock and the injury sustained by nurse (small burn to leg).The device was being used for patient handling at the time the incident.Upon the conducted investigation and bed inspection done by the arjohuntleigh representative, we were able to determine that bad condition of mains lead could be contributing factor to the electric shock occurrence, however we are not in position to determine who is responsible for its damage.The device was reported to cause an electric shock and from that perspective, the enterprise 8000 bed did not meet its manufacturer's specification.

Event Description

On (b)(4) 2017 arjohuntleigh was notified about a complaint involving enterprise 8000 bed.Following information provided the nurse who came over to give treatment to the patient lying on the bed received electric shock.The incident took place while her leg touched the metal bar at the side of the bed.In consequence she sustained small burn to leg.No other outcomes were reported.The involved nurse was not hospitalized, no medical intervention was required.

• Brand Name: ENTERPRISE 8000
• 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: 7132870
• MDR Text Key: 96008287
• Report Number: 3007420694-2017-00231
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 12/20/2017
• Distributor Facility Aware Date: 12/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2017
• Date Manufacturer Received: 12/05/2017
• 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