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

Model Number 8X23GD113BAAAA

Device Problems Failure to Charge (1085); Unintended Movement (3026); No Apparent Adverse Event (3189)

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

Event Date 07/22/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.When final conclusion is available, a follow-up report will be provided.

Event Description

Customer reported that the bed moved by itself.The customer suspected an error with controls.When arjo service technician inspected the bed he was able to confirm the customer allegation.The bed raised up on its own when the technician lifted the side rail, however when check the wiring he did not find any damage.Unintended movement was not observed again.

Manufacturer Narrative

Investigation is ongoing.When final conclusion is available, a follow-up report will be provided.

Manufacturer Narrative

Based on the collected information the root cause of the complained battery malfunction is considered normal wear.The history of complaints and service repairs did not show any records since the bed was manufactured in february 2015.The preventive maintenance was performed on a regular basis yearly on this bed, but there is no evidence of battery replacement throughout those years, as the bed was working as intended.The ifu for enterprise 8000x bed (746-585-en) includes the following information related to the battery maintenance: "check that the bed operates correctly using the backup battery as described in the section battery test [of the ifu]" - this preventive maintenance activity is to be performed yearly by qualified personnel."to maintain best performance, the backup battery should be replaced every four years by an approved service agent".Arjo device failed to meet its performance specification since the battery was not charging.The device was not used for a patient treatment when the malfunction occurred.Based on the clarified information the complained scenario does not create any risk of serious injury or death for the patient or user, therefore it is not considered a reportable scenario and will not be reported in the future.

Event Description

Following the initial information provided it was reported that the bed moved by itself and then stopped working at all.Upon further clarification it was established that the initial allegation was incorrect and not related to the complained enterprise 8000x bed.The only subject of this complaint was confirmed to be a non-functional battery backup, resulting in lack of charging.There was no unindended movement complained.There is no indication of patient involvement.No injury was sustained.

• 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
• 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: 15259095
• MDR Text Key: 305348309
• Report Number: 3007420694-2022-00135
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8X23GD113BAAAA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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