MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 5000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number E5X3PR133DFDBA

Device Problem Fracture (1260)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo received a customer complaint for enterprise 5000x bed.According to the information provided the enterprise 5000x bed was found with damaged hinge and there was no possible to raise or lower the backrest of the bed.It was indicated that probably there was a patient in the bed when the issue occurred.No injuries were reported.

Manufacturer Narrative

Arjo received a customer complaint for enterprise 5000x bed.According to the information provided the enterprise 5000x bed was found by an arjo technician with damaged hinge (this defect was confirmed by the photo evidence received) and it was not possible to raise or lower the backrest of the bed.The malfunction was detected during device operation therefore it was indicated that a patient was placed on the bed when the issue occurred.No injuries were reported.Based on the photographic evidence provided, one of two backrest hinges was broken.The hinge consists of two components that broke off from each other.The photographic evidence and information gathered in the course of this investigation were consulted with the technical department.It seems most likely that the hinge damage was a result of hinge casting class not followed by the supplier.The production was transferred from this supplier in 2019.The involved enterprise 5000x bed was manufactured before this date, in dec 2017.Arjo device failed to meet its performance specification since the hinge broke.The device was used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of hinge failure during use with the patient which might have contributed to collapse of the backrest section.No injury was reported.

• Brand Name: ENTERPRISE 5000X
• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16581502
• MDR Text Key: 311693040
• Report Number: 3007420694-2023-00056
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097331072
• UDI-Public: (01)05056097331072(11)171207
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: E5X3PR133DFDBA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• 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