MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 9000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 9X24BD121FAAAA

Device Problem Unintended Movement (3026)

Patient Problems Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2022

Event Type  malfunction  

Event Description

Following the initial information provided, the bed platform moved unintended, allegedly pulling the drain out of patient's chest as a result.The evaluation of the bed confirmed that the nurse control panel had an electrical failure that caused the bed to move without command given.Further information are being collected.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once available.

Event Description

The information provided indicates that the bed started to move on its own.It has not been confirmed which part of the device caused the unintended movement.During the incident, a patient was lying on the bed with a drainage tube connected to the chest.As a result of the unintended bed movement, the drainage tube was ¿knocked over¿ (folded over) from the patient¿s chest, but still in place.The patient did not sustain any injury.

Manufacturer Narrative

Arjo was informed about three events involving the enterprise 9000x bed.The events were reported under following medwatch and mhra reports numbers: 1st event ¿ arjo reference number: tw2153629: medwatch report number: 3007420694-2022-00021, mhra report number: 2022/002/011/601/003, 2nd event - arjo reference number: tw2156670: medwatch report number: 3007420694-2022-00035, mhra report number: 2022/003/003/601/504, 3rd event - arjo reference number: tw2156658: medwatch report number: 3007420694-2022-00034, mhra report number: 2022/003/003/601/503.This report concerns the first event, which was reported under the medwatch number: 3007420694-2022-00021 and mhra number: 2022/002/011/601/003 (arjo reference number: (b)(4)).The information provided indicates that the bed started to move on its own.It has not been confirmed which part of the device caused the unintended movement.During the incident, a patient was lying on the bed with a drainage tube connected to the chest.As a result of the unintended bed movement, the drainage tube was ¿knocked over¿ (folded over) from the patient¿s chest, but still in place.The patient did not sustain any injury.The bed frame was not excluded from use until the third event.The bed frame inspection conducted following this third event reported under 3012292104-2021-00034 number (arjo reference number: (b)(4)) revealed a faulty acp (attendant control panel).It is unknown if this part was in anyway responsible for the claimed unintended bed frame movement as the inspection was not performed for the first event.Based on the information above, the root cause of the device malfunction cannot be determined.To sum up, while the event occurred, the device was used for a patient treatment.The system failed to meet its performance specification since unintended movement occurred.The complaint was decided to be reportable due to allegation of an unintended bed movement.No injury was reported.

• Brand Name: ENTERPRISE 9000X
• 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: 13659201
• MDR Text Key: 286506486
• Report Number: 3007420694-2022-00021
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05059441138440
• UDI-Public: (01)05059441138440(11)201005
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9X24BD121FAAAA
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2020
• 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