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

Model Number 8X23G4113DBAFB

Device Problem Use of Device Problem (1670)

Patient Problems Physical Entrapment (2327); Limb Fracture (4518)

Event Date 07/13/2023

Event Type  Injury  

Event Description

Arjo has been notified of an incident involving the enterprise 8000x bed.It was indicated that a student broke the middle toe.It was reported that the student was not wearing shoes in the workshop and placed the foot on the floor under the enterprise bed.The bed was slightly tilted and the bed castor was slightly above the ground.There was a bin under the bed which lifted the bed on the one side.The bed dropped onto her foot once the bin gave way.As a result, the student suffered a foot injury.

• Brand Name: ENTERPRISE 8000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 17496447
• MDR Text Key: 320760842
• Report Number: 1419652-2023-00047
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097315898
• UDI-Public: (01)05056097315898(11)201007
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8X23G4113DBAFB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2023
• Distributor Facility Aware Date: 07/13/2023
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 08/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female