MAUDE Adverse Event Report: ENTERPRISE 5000; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skull Fracture (2077)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).On 2018-may-14 arjo was notified by police officer about the non-accidental patient's injury involving enterprise 5000 bed.The case is currently under police investigation.The incident took place in (b)(6).Following the information reported the (b)(6) baby was dropped on hospital floor.As a result the baby sustained bilateral skull fracture.We were also informed that the mother of the baby had raised the overall height of the bed.The incident was unwitnessed.On 2018-may-16 we were informed by customer facility representative that they could not identify the bed that was actually involved in the incident (date of event (b)(6) 2017) and that no more information will be available in this matter.Due to the fact the device involved in the incident could not be identified we were not in position to inspect the bed in question.Although the exact circumstances of the event remains unknown, we were informed by police officer that the drop of the baby was non-accidental what indicates that the injury could have been deliberate.Based on the above we see no association between our device and the injury sustained.The complaint was decided to be reportable due to the drop of the baby and the injury sustained.At the time the incident occurred there was a patient present on the bed.There was no indication of bed's malfunction, therefore we assume the enterprise 5000 bed was working up to manufacturer's specification at the time of the incident.

Event Description

On 2018-may-14 arjo was notified by police officer about the non-accidental patient's injury involving enterprise 5000 bed.The case is currently under police investigation.The incident took place in (b)(6).Following the information reported the (b)(6) baby was dropped on hospital floor.As a result the baby sustained bilateral skull fracture.We were also informed that the mother of the baby had raised the overall height of the bed.The incident was unwitnessed.

Manufacturer Narrative

This report is being filed under exemption: e2012070 by arjohuntleigh polska sp.Z o.O.(registration#: (b)(4) on behalf of the importer arjohuntleigh, inc.(ahus) (registration#: (b)(4).This is the follow up report to the final report with a correction: the baby that sustained injury was two days old, not 2 years old as stated in the conclusions of final report.

• Brand Name: ENTERPRISE 5000
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• MDR Report Key: 7581587
• MDR Text Key: 110467396
• Report Number: 3007420694-2018-00118
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2018
• Distributor Facility Aware Date: 05/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 DA