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

Model Number 5000BA22A12BA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 12/25/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.Results of the investigation will be provided to the follow-up report.

Event Description

Following information reported backrest section of the enterprise 5000 bed collapsed when the patient was lying on the bed.This resulted in patient vomiting and not being able to be extubated.The medical intervention was required.After this incident, the patient was placed on the another bed.

Manufacturer Narrative

The device evaluation was carried out by arjo representative.It was confirmed that the backrest section of the bed collapsed due to the broken hinge responsible for holding head and middle sections of the bed.The analysis is still ongoing.The results of the analysis will be provided upon investigation completion.

Manufacturer Narrative

Arjo was informed about the event, which occurred with the participation of the arjo enterprise 5000 bed in the bradford royal infirmary in the uk.Following initial information reported by the customer, the backrest collapsed when the patient was sitting in the upright position.This resulted in patient vomiting and not being able to be extubated.Medical intervention was required.Despite our best effort, we have not managed to collect information regarding patient health conditions, either pre-existing nor post-incident.During inspection carried out by arjo representative, it was confirmed that this event was caused through a ruptured hinge on one side of the bed - that holds the backrest and seat section of the bed.The hinge on the other side of the bed was sprained, however it was not broken.The involved bed was manufactured on 17 mar 2008 and was serviced by the third-party service company.The service history was not provided by the facility, therefore it could not be confirmed whether the bed was serviced regularly according to the procedure described in the instructions for use.Based on that the exact cause of the hinge breakage on the twelve-year-old device could not be determined.To sum up, there was a patient on the bed when the hinge broke and the backrest collapsed unexpectedly.The enterprise 5000 bed did not meet the specification during the event.It was decided to report this complaint given the particular circumstances of the event ¿ the intubated patient who vomited and could not be extubated.

• Brand Name: ENTERPRISE 5000
• 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
• MDR Report Key: 9699504
• MDR Text Key: 189595419
• Report Number: 3007420694-2020-00027
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5000BA22A12BA
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention