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

Model Number 9X22BW111BCAGB

Device Problem Human Factors Issue (2948)

Patient Problem Injury (2348)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2018 arjohuntleigh received a customer complaint involving enterprise 9000x.The reported malfunction took place in (b)(6).Following information provided the patient rolled onto one side of the bed, hung his arm over the safety side and released safety side handle.As a consequence the safety side became lowered and the patient fell out of the bed.The nurse was in a position to grab the patient to prevent him from hitting the floor.As a result of this activity the nurse received minor hand injury.After the event occurrence the bed was inspected by arjohuntleigh technician in regards to the alleged incident.The evaluation revealed that the device was in general good condition with no obvious faults identified.All the electrical bed's functions were working as intended.It needs to be emphasized that 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.To ensure the safety of our products the instruction for use (e.G.746-591_en_2) includes the following information and warnings: -warning: " make sure the locking mechanism is securely engaged when the split side rails are raised".-information: "check operation of split side rails"- daily.Upon the conducted investigation and bed inspection done by the arjohuntleigh representative, it was established that the patient's fall occurred due to safety side being lowered.According to the information provided within the complaint the patient reached the safety side panel and released it by the accident.Taking into account the sequence of events which have led to the patient's fall we see this complaint to be an unfortunate coincidence.In summary, although there was no injury reported the complaint was decided to be reportable on a potential of serious health consequence upon patient's fall recurrence.The device was being used for patient care at the time of the incident.The investigation conducted revealed that the user error contributed to the incident (safety side being lowered by accident).There was no product malfunction found within the device and from that perspective it was assumed that at the time the patient's fall occurred the device was working up to manufacturer's specification.

Event Description

On (b)(6) 2018 arjohuntleigh received a customer complaint involving enterprise 9000x.The incident took place in (b)(6).Following information provided the patient rolled onto his side, hung his arm over the safety side and released safety side handle.As a consequence the safety side became lowered and the patient fell out of the bed.The nurse was in a position to grab the patient to prevent him from hitting the floor.As a result of this activity the nurse received minor hand injury.

• 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
• 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: 7246944
• MDR Text Key: 99816211
• Report Number: 3007420694-2018-00031
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9X22BW111BCAGB
• 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: 02/07/2018
• Distributor Facility Aware Date: 01/16/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2018
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• 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