MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; BED, MANUAL

Model Number P1190A000045

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the bed exit alarm was not working.And that one of the ppm mode systems leds was lit on one of the scale pods and could not be turned off.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hillrom technician suggested to isolate the siderails one at a time.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 showed hillrom performed preventative maintenance on this bed on (b)(6) 2023.It is unknown if the facility performed any other preventative maintenance on this bed.Hillrom technical support contacted the account two additional times trying to obtain the resolution for this event.No response has been received from the account based on this information, no further action is required.

• Brand Name: ADVANTA 2 FRAME
• Type of Device: BED, MANUAL
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 17338183
• MDR Text Key: 319216310
• Report Number: 3006697241-2023-00069
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P1190A000045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1