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

Model Number E5X2FC103BCASB

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 12/13/2019

Event Type  Injury  

Event Description

Following information reported by (b)(6) hospital in (b)(6), a caregiver's finger got hurt when operating the side rail of the enterprise 5000x bed.This injury required closure with sutures.

• Brand Name: ENTERPRISE 5000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 9494509
• MDR Text Key: 186185477
• Report Number: 1419652-2019-00214
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982747707
• UDI-Public: (01)05055982747707(11)190618
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: E5X2FC103BCASB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention