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

Model Number 8000BA22A12BA

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the photographic evidence provided by the distributor, the backrest hinge broke into two pieces.No other damages were observed.The issue was consulted with the arjo product engineer who advised that the wear of the hinge components is the most probable root cause as the device was 14 years old based on the manufacturing date.Arjo device failed to meet its performance specification since damaged component was observed.This complaint is deemed reportable due to allegation of hinge breakage during use of the bed with the patient.No injury occurred as an outcome of the claimed malfunction.

Event Description

The distributor contacted arjo to inform that the enterprise 8000 bed hinge connecting the backrest and the main section of bed frame broke in two pieces.It occurred during lowering of the backrest with the patient on the bed.No injury was reported.

• Brand Name: ENTERPRISE 8000
• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17805851
• MDR Text Key: 324107318
• Report Number: 3007420694-2023-00228
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8000BA22A12BA
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2009
• 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