MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP.Z O.O. ENTERPRISE 5000X

Model Number E5X3QZ10CN4551

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 5000x is designed for high dependency patients who pose a movement and handling risk and/ or whose clinical condition requires that they are positioned with minimal physical handling.Each enterprise 5000x bed is equipped with manual cpr release handles located below the calf section on either side of the bed that shall be activated in emergency situation.This feature is responsible for lowering the backrest to the horizontal position to enable cardio-pulmonary resuscitation to be carried out.On (b)(6) 2017, arjohuntleigh has received a customer complaint involving enterprise 5000x (serial number: (b)(4)).The reported malfunction took place in the (b)(6) hospital.The customer allegation was that mechanical cpr did not activate while the cpr release handle was pulled.Afterwards the backrest section of the device suddenly dropped down to the horizontal position.The event occurred while the patient was intubated.As a result the resident did not suffer any injury.The intubation was completed successfully.After the event, the device was moved through the arjohuntleigh inspection where the mechanical cpr failure was affirmed and as a corrective action, the backrest actuator was replaced and cpr cables were tightened up.However technician was not able to confirm backrest fall as the gas spring responsible for amortizing movement of backrest section of the device was working correctly during device inspection.After part replacement and cables adjustment the device started working as per manufacturer specification and was released for customer use.Based on the collected information and findings made during part inspection it was affirmed that the actuator housing where the cpr cables are located cracked off.Unfortunately, despite of our best effort we were unable to receive photographic evidence of part damage.During the review of similar complaints associated with manual cpr malfunction only one complaint was found with above mentioned statement (recorded in jul 2012, no information about patient's injury was provided).In line with this information we can only presume that the continuity of actuator housing structure become disturbed before the incident occurred what subsequently led to the housing lid impairment and resulted in total part damage (opened housing lid), nevertheless due to limited information we were not able to confirm or deny this theory.To ensure the safety of our products the instruction for use provided together with the involved device (746-577 rev.7 dated on may 2016) warns the user how to operate the device safely: warning: "when the bed is operated, make sure that obstacles such as bedside furniture do not restrict its movement." warning: " 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." additionally, in order to ensure that the device continues to perform within its original specification; the operation of manual cpr release handles should be checked weekly by carer.Moreover preventive maintenance procedure should be carried out annually by properly qualified and trained persons.One of the steps of the preventive maintenance is to check operation of the manual cpr release levers on both sides of the bed.Please note also that on enterprise 5000x bed there are two cpr systems - even if one of them failed, the mattress platform still can be lowered to horizontal position by using the other system (electrical one) in result allowing carrying out the cardiopulmonary resuscitation.In summary the device failed to meet its specification, it was being used for patient's intubation at the time of event, there were no injuries sustained as a result of the incident and the intubation was completed successfully.Although in this event there were no health consequences to the patient, based on a potential for harm we have decided to report the event in an abundance of caution.With amount of sold devices on the market, the complaint ratio for reportable complaints with this failure mode is considered to be low.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On (b)(6) 2017, arjohuntleigh has received a customer complaint involving enterprise 5000x (serial number: (b)(4)).The reported malfunction took place in (b)(6)hospital.The customer allegation was that mechanical cpr did not activate while the cpr release handle was pulled.Afterwards the backrest section of the device suddenly dropped down causing the device to be flatten out.The event occurred while the patient was intubated.As a result the patient did not suffer any injury.

• Brand Name: ENTERPRISE 5000X
• Type of Device: ENTERPRISE 5000X
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP.Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP.Z O.O.; 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 ; 98282467
• MDR Report Key: 6474983
• MDR Text Key: 72412917
• Report Number: 3007420694-2017-00075
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: E5X3QZ10CN4551
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2017
• Distributor Facility Aware Date: 03/19/2017
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2017
• Date Manufacturer Received: 03/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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