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

Model Number 9X22BQ111AFABA

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2017 arjohuntleigh received a customer complaint involving enterprise 9000x (serial number: (b)(4)).The reported malfunction took place in the (b)(6) in (b)(6).Following information provided the patient laying on bed suffered a cardiac arrest.To flatten the mattress platform to the horizontal position to enable cardio-pulmonary resuscitation to be carried out the bed's electric cpr control button was pressed.Despite button activation the cpr function did not work.At the time the malfunction occurred anti entrapment system (aes) code was displayed on control panel and all the lights from the panel were blinking.No injury was reported in relation to presented sequence of events.The patient was successfully resuscitated using manual cpr function.All manufactured enterprise 9000x beds are checked before being distributed to the customers to verify if the product meets the required manufacturer's specifications and check whether the acceptance 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.Based on the above the manufacturer defect was ruled out to be a cause of the problem occurrence.After the malfunction occurrence the bed in question was inspected by arjohuntleigh technician.The evaluation revealed that aes sensor was not correctly aligned.As a consequence, this failure led to the situation where the bed identified the obstruction which was actually not present under the bed.It restricted bed's lowering movement.To restore the functionality of electric cpr the technician made an adjustment of aes sensor.There were no other technical deficiencies found within the device.To ensure the safety of our products the instruction for use provided together with the involved device (746-591_en_8) includes the following warnings and information: - information: "when the bed is operated, make sure that obstacles such as bedside furniture do not restrict its movement", - information: "take care not to allow clothing or bed linen to become snagged on moving parts of the bed", - warning: "the backrest can fall quickly; keep hands clear to avoid trapping", - warning: "the manual cpr release should only be used in an emergency; repeated everyday use cause premature wear", - information: weekly - "check operation of the manual cpr release handles on both sides of the bed".- information: " the anti-entrapment system may also be triggered if the beam is interrupted by bed linen etc." - warning: "clean the lenses of the infra-red sensors regularly using soft dry cloth." although there were no injuries reported, the complaint was decided to be reportable due to bed's electric cpr malfunction in an emergency situation (patient's cardiac arrest).Upon the conducted investigation and device inspection done by the arjohuntleigh representative, we were able to determine that the event was caused by aes sensor which was not correctly aligned, but we were not able to establish the exact root cause and sequence of events which have led to the issue occurrence.Based on all above we conclude that at the time the malfunction occurred the enterprise 9000x was not working up to manufacturer's specification.

Event Description

On (b)(6) 2017 arjohuntleigh received a customer complaint involving enterprise 9000x (serial number: (b)(4)).The reported malfunction took place in the (b)(6) in (b)(6).Following information provided the patient was laying on bed, when suffered cardiac arrest.The electric cpr control button was pressed to flatten the mattress platform to the horizontal position and enable the cardio-pulmonary resuscitation to be carried out.Despite button activation the cpr function did not work.At the time the malfunction occurred anti entrapment system code was displayed on control panel and all the lights from the panel were blinking.No injury was reported in relation to this incident.The patient was successfully resuscitated using manual cpr function.

Manufacturer Narrative

This report is being filed under exemption e2012070 (b)(4).This is a follow up report to the final report 3007420694-2018-00007 with correction.On 14-dec-2017 arjohuntleigh received a customer complaint involving enterprise 9000x (serial number: (b)(4)).The reported malfunction took place in the aubagne cl casamance in france.Following information provided the patient laying on bed suffered a cardiac arrest.To flatten the mattress platform to the horizontal position to enable cardio-pulmonary resuscitation to be carried out the bed's electric cpr control button was pressed.Despite button activation the cpr function did not work.At the time the malfunction occurred anti entrapment system (aes) code was displayed on control panel and all the lights from the panel were blinking.When aes code was cleared the e410 error code appeared on the display.It blocked all the electrical function and restricted bed's lowering movement.No injury was reported in relation to presented sequence of events.The patient was successfully resuscitated using manual cpr function.All manufactured enterprise 9000x beds are checked before being distributed to the customers to verify if the product meets the required manufacturer's specifications and check whether the acceptance 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.Based on the above the manufacturer defect was ruled out to be a cause of the problem occurrence.After the malfunction occurrence the bed in question was inspected by arjohuntleigh technician.The evaluation revealed that aes sensor was not correctly aligned.The technician made an adjustment of aes sensor.There were no other technical deficiencies found within the device.It needs to be emphasized that the error code e410 which appeared during the incident after the aes was cleared is a general error code which notifies about some electric malfunction within the device.It blocks also all control panel functions (incl.Electric cpr), the cause of its occurrence was not identified.To ensure the safety of our products the instruction for use provided together with the involved device (746-591_en_8) includes the following warnings and information: - information: "when the bed is operated, make sure that obstacles such as bedside furniture do not restrict its movement", - information: "take care not to allow clothing or bed linen to become snagged on moving parts of the bed", - warning: "the backrest can fall quickly; keep hands clear to avoid trapping", - warning: "the manual cpr release should only be used in an emergency; repeated everyday use cause premature wear", - information: weekly - "check operation of the manual cpr release handles on both sides of the bed" - information: " the anti-entrapment system may also be triggered if the beam is interrupted by bed linen etc." - warning: "clean the lenses of the infra-red sensors regularly using soft dry cloth." although there were no injuries reported, the complaint was decided to be reportable due to bed's electric cpr malfunction in an emergency situation (patient's cardiac arrest).Upon the conducted investigation and device inspection done by the arjohuntleigh representative, we were not able to establish the exact root cause and sequence of events which have led to the issue occurrence.Based on all above we conclude that at the time the malfunction occurred the enterprise 9000x was not working up to manufacturer's specification.

• Brand Name: ENTERPRISE 9000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7167034
• MDR Text Key: 96822208
• Report Number: 3007420694-2018-00007
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 9X22BQ111AFABA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2018
• Distributor Facility Aware Date: 12/14/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2018
• Date Manufacturer Received: 12/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other