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

Model Number 9625A21CON6614

Device Problem Delayed Alarm (1011)

Patient Problem Fall (1848)

Event Date 11/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information provided the customer complained that the exit alarm activated with a delay.After the activation of exit alarm, the nurses went to the room and found the patient lying on the floor.There is no indication of any injury sustained.The evaluation of the bed performed after the event confirmed that the bed was working in accordance to the specification, no malfunction was detected.

Event Description

Following the information provided the patient fell from the enterprise 9000x bed.There is no indication of any injury sustained.There was an allegation that the exit alarm activated with a delay.After the activation of the exit alarm, the nurses went to the room and found the patient lying on the floor.The bed egress alarm allegedly activated with a delay when the incident occurred, but it could not be confirmed during the bed inspection.The weighting scale and the varizone patient movement detection system (which can be set to alarm when undesired movement of the patient occurs) were tested and no abnormality was found.

Manufacturer Narrative

Based on the review of post-market surveillance data and an arjo service manager's assessment, the bed was deemed working as intended and there was no fault found.The device was used for patient treatment when the event occurred.No malfunction was found on the device and it was working as intended.This complaint is deemed reportable due to alleged patient's fall from the bed.

• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15904168
• MDR Text Key: 307908776
• Report Number: 3007420694-2022-00200
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056341699767
• UDI-Public: (01)05056341699767(11)191010
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9625A21CON6614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• 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