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

Model Number E5X2HD103BBAAA

Device Problem Device Tipped Over (2589)

Patient Problems Bruise/Contusion (1754); Hematoma (1884); Laceration(s) (1946)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The inspection performed internally by the facility revealed that the bed was in overall good condition without any damages or malfunction evident and was returned for use.The facility representative informed that the bed is not available for arjo technician evaluation.The facility staff confirmed that the reason the bed tilted was an obstruction (non-arjo air warming device) under the bed which prevented the bed platform from lowering evenly.The instructions for use dedicated to enterprise 5000x (746-577-uk) contain all crucial information and warnings which should be followed to ensure the safe use of the bed, e.G: ¿when the bed is operated, make sure that obstacles such as bedside furniture do not restrict its movement.¿ to conclude, the arjo device was used for a patient treatment when the event occurred and from that perspective, it played a role in the event.Arjo device failed to meet its performance specification since the bed tilted downwards.No malfunction was found during the device evaluation.The complaint was decided to be reportable due to the allegation of a patient fall.

Event Description

Arjo has received an adverse incident report from (b)(6) indicating that during lowering the enterprise 5000x bed platform using control buttons, the bed tilted downwards causing the patient to fall from a height of about 60 cm.The patient sustained cheek and chin laceration, bruising on the left hand, and a left psoas hematoma.A staff nurse sustained a 15 cm leg laceration due to contact with the tilting bed.

• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 11264588
• MDR Text Key: 232587046
• Report Number: 3007420694-2021-00012
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982747424
• UDI-Public: (01)05055982747424(11)170227
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E5X2HD103BBAAA
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2017
• 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