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  

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.

• 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: 9699503
• MDR Text Key: 188483572
• Report Number: 1419652-2020-00009
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2020

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2020
• Distributor Facility Aware Date: 01/14/2020
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention