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

Device Problem Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2019 arjo was informed about the event regarding patient's head entrapment around the enterprise 8000 bed rails, which occurred in hospital civils de colmar in france.The facility informed arjo about this event a few months after the incident took place (event happened in (b)(6) 2018).It was indicated by the facility that the patient sustained injury, however more details were not provided.Based on the available information, hospital civils de colmar is equipped with multiple enterprise 8000 medical beds.The facility staff was unable to point out specific serial number that was involved in the event from (b)(6) 2018.Without knowing which device was involved and taking into account that arjo was informed several months after the event took place , the technical evaluation was impossible to be carried out.The arjo medical beds in this facility are not under arjo service and maintenance contract.Taking into account limited information gathered, the exact cause of the patient's head entrapment could not be established.It should be emphasized that the instruction for use dedicated to enterprise 8000 bed (e.G.746-435 rev.7) contains all crucial information and warnings which should be followed to ensure patient safety: - "where risk assessment indicates that a patient is at high risk of entrapment owing to their medical condition or other circumstances, and where there are no medical benefits from their being left in a contoured position, place the mattress platform in the flat position when patient is left unattended." - "before operating the bed, make sure that the patient is positioned correctly to avoid entrapment or imbalance.".It is recommended that prior to use of the product all sections for instruction for use are to be reviewed, particular attention is to be given to warnings.The instruction for use instructs how to operate the bed.Apart from writing instructions, it presents graphics which explain how to use particular functions of bed e.G.Side rails.If information included in the ifu is followed, the risk of any hazardous situation is minimized.During review similar reportable events for the enterprise 8000 medical beds, 2 events regarding patient's head entrapment were found (including one, which is subject of this report).Summarizing, when the event occurred the bed was used for a patient treatment and in that way played a role in the reported incident.It was not possible to determine which enterprise 8000 medical bed was involved in the event and the inspection could not be carried out.Due to this fact, it cannot be confirmed whether the involved device meet the manufacturer's specifications during the event.The complaint decided to be reportable due to the allegation of patient's head entrapment and injury occurrence.

Event Description

On (b)(6) 2019 arjo was informed about the event regarding patient's head entrapment around the enterprise 8000 bed rails, which occurred in hospital civils de colmar in france.The facility informed arjo about this event a few months after the incident took place (event happened in (b)(6) 2018).It was indicated by the facility that the patient sustained injury, however more details were not provided.

• Brand Name: ENTERPRISE 8000
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O; 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: 8436019
• MDR Text Key: 142780656
• Report Number: 3007420694-2019-00051
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2019
• Distributor Facility Aware Date: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2019
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: No
• 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