MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O. O. ENTERPRISE 9000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 9X22BX111DCAGB

Device Problem Non Reproducible Results (4029)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

On (b)(6) 2018 arjo received information regarding the incident involving enterprise 9000x bed.Following the information provided the electric cpr was not working due to error e410.Patient's condition was rapidly deteriorating and a decision was made by the staff to urgently move the patient to another bed.The patient lost consciousness and a rapid response (cpr) was initiated (patient already on a new bed).Nevertheless the patient died.During bed's inspection conducted by arjo representatives it was revealed that the facility staff did not use manual cpr while electrical one failed to operate.Bed's evaluation was completed successfully, both cprs were working correctly.Additionally we were informed that information regarding patient's pre-existing condition and cause of the death will not be disclosed due to the hospitals privacy requirements.However we received the following statement from a nurse unit manager "the bed failure did not change the outcome for the patient".

Manufacturer Narrative

This report is being filed under exemption e2012070 by arjohuntleigh polska sp.Z o.O.(registration#(b)(4)) on behalf of the importer arjohuntleigh, inc.(ahus) (registration#(b)(4)).On 01-nov-2018 arjo was notified about the incident involving enterprise 9000x bed.The reported malfunction took place in the (b)(6) hospital in australia.Following the information reported error code e410 (service error which required technical investigation) appeared on control panel display blocking all bed electrical functions, including electric cpr.This malfunction occurred at that time the doctor was reviewing critically ill patient (over 60 years old female) laying on the bed in question.It was tried by facility staff to clear the error code, however without success.Then the power cord was unplugged, when plugged back in the control panel functions were still blocked.In the meantime patient's condition rapidly deteriorated and a decision was made to urgently move her to another bed.While preparing the patient for being transferred, she lost consciousness.Then the patient was rapidly moved from not working bed, to the new one using sliding sheet and a cardiopulmonary resuscitation was immediately commenced.Despite this, the patient passed away.It needs to be emphasized that the enterprise 9000x beds are equipped with two types of cprs: electrical and mechanical one.The electrical cpr is operated with use of press button placed on the attendant control panel (acp).Activation of this function lowers all deck sections to a flat position.The manual cpr is activated with use of levers placed one on each side of the bed.The lever is connected mechanically by a cable with the actuator.It allows to lower the backrest to a flat position without assistance of electrical control panel.Even though the electric cpr is not working, as per device design, the secondary safety feature manual cpr can still be used instead and provide safe lowering of the patient to a flat position.Therefore, even if electrical component (cpr) fails (as was stated in this specific situation), the secondary safety feature would override the failure allowing to lower the bed to flat position.According to the information provided by the facility staff, a manual crr (although it was confirmed to be working correctly) was not used at the time the incident occurred.After receiving the communication about the malfunction occurrence, arjo service technician was dispatched to conduct the bed's inspection with regards to the alleged issue.He checked the sub error code which was e303- fatal error code.This is the reason he changed the control box and replaced the battery.During bed's evaluation no error code e410 appeared on control panel display.Both cprs (electric and manual cpr) were working up to manufacturer's specification.As per information provided, arjo was responsible for servicing the device in question.The date of last preventive maintenance is 23-oct-2018.The information regarding patient's pre-existing condition and clinical opinion from hospital regarding the actual cause of patients death were not disclosed by facility staff due to hospitals privacy requirements.However we received nurse unit manager statement confirming that bed failure did not change the outcome for the patient.It needs to be emphasized that relevant product instruction for use is delivered with each device (e.G.746-591 rev.11 for enterprise 9000x bed) contains general manufacturer's recommendations how to use, clean and maintain the device in a good condition.The instruction on how to use cpr's (electrical and manual) are thoroughly described and documented.The customer was trained on how to use the device following bed's purchase.The enterprise 9000x bed (serial number: p0406322) was checked during quality inspection gate to verify the required product specifications and check whether the acceptance performance criteria are met.Records of the inspection are documented in the device history record (dhr).The device history record has been reviewed for this specific device and no anomaly was found.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.The complaint was decided to be reportable due to the allegation of patient's death and not working electric cpr in situation requiring medical intervention.At the time the malfunction occurred there was a patient lying on the bed.The electric cpr was not working and from that perspective, the enterprise 9000x bed did not meet its manufacturer's specification.

• Brand Name: ENTERPRISE 9000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O. O.; ks. wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 8050170
• MDR Text Key: 126505493
• Report Number: 3007420694-2018-00211
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097303901
• UDI-Public: (01)05056097303901(11)161103
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9X22BX111DCAGB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2018
• Distributor Facility Aware Date: 11/01/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2018
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR