MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z.O.O. ENTERPRISE 9000

Model Number 9800BN72A11AU3

Device Problem Delayed Alarm (1011)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2014

Event Type  Injury  

Event Description

It has been indicated by the customer that the customer that the pt fell to the floor from enterprise 9000 bed, it is unk how long the pt was on the floor until the exit alarm was triggered.In accordance to information provided by the facility the exit alarm was working during the day, but as its sensitivity was sent on a high level, the bed kept alarming event with small movement of the pt, therefore some time before the incident the alarm sensitivity has been reduced, by raising the threshold level to 1 (from 0,5).Reference mfr# 3007420694-2014-00047.

• Brand Name: ENTERPRISE 9000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z.O.O.; ul. ks. piora wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3764895
• MDR Text Key: 4549127
• Report Number: 1419652-2014-00103
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9800BN72A11AU3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2014
• Distributor Facility Aware Date: 03/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other