MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1190A000093

Device Problem Device Alarm System (1012)

Patient Problem Head Injury (1879)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

The hillrom technician tested the bed and found the bed to be working as designed, no malfunction found with the bed.Head trauma could encompass a variety of conditions, but in the absence of further clarification, it is considered a reportable serious injury.Additionally, while the bed functioned as designed at the time of inspection, it is unknown what occurred at the time of the event in which the bed exit did not alarm.Thus, hillrom is reporting this event in an abundance of caution.Per the hillrom user manual, warning: the bed exit alarm system is not intended as a substitute for good nursing practices.The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician found no malfunction with the bed , the bed was working as designed and it was a user error which resulted in patient serious injury.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the exit alarm was not working resulting in patient serious injury.It was reported that due to the bed exit not alarming upon a patient's exit from the bed, the patient fell and experienced head trauma.Despite multiple attempts to clarify the head injury and outcome, no additional information was forthcoming.The bed was inspected on site a day after the incident and it functioned as designed, including the bed exit.The bed was located at the account.There was serious patient injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ADVANTA 2 FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 11527537
• MDR Text Key: 241031750
• Report Number: 3006697241-2021-00022
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P1190A000093
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening