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

Model Number E5X2HD103BAAAA

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.Conclusions will be provided within the follow up report once the investigation is completed.

Event Description

Following the information provided the bed was found in the bedstore by arjo technician.It was damaged with twisted backrest and frame as if the backrest had been raised against an immovable object.The photographic evidence provided shows that the lower arm of head left side rail was detached from its mounting point at the bed, resulting in the side rail hanging freely.There is no indication of patient involvement.No injury was sustained.

Manufacturer Narrative

The investigation is in progress.Conclusions will be provided within the follow up report once the investigation is completed.

Manufacturer Narrative

Following the information provided the safety side was partially detached.The circumstances of the damage occurrence remained unknown as the bed was found in in the bed store.The bed was taken out of use.The evaluation provided, revealed that the bed frame was bent and the side rail was damaged (the side rail lower arm was detached from the bed frame).There is no allegation of patient involvement.No injury was sustained.The review of post-market surveillance data revealed that the main factor which could lead to the side rail detachment might be related to an excessive force applied to the side rail.This is in line with the bed frame condition: the side rail panel was partially detached from the bed frame and dent in moulding was visible, additionally, the bed frame was bent.The observed damages may indicate that the side panel was blocked by the obstacle during the raising of the backrest.The photography evidence provided to complaint showed that wall fittings which were installed near the bed safety side may obstruct the side rail movement.The instructions for use for enterprise 5000x (746-577-en) include the instructions for safe operation to avoid damage of the side rails as follows: ¿when the bed is operated, make sure that obstacles such as beside furniture do not restrict its movement." "check operation of side rails" - this is a preventive maintenance activity to be performed daily by the caregiver.Arjo device failed to meet its performance specification since the side rail panel was partially detached from the side rail mechanism and the bed frame was bent.There was no allegation of any patient involvement.No injury was claimed.This complaint is deemed reportable due to the safety side detachment from the bed frame.

• 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: 15868308
• MDR Text Key: 307999309
• Report Number: 3007420694-2022-00195
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982747431
• UDI-Public: (01)05055982747431(11)210416
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: E5X2HD103BAAAA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• 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