MAUDE Adverse Event Report: HILL-ROM, INC. ASBC, REV B AUDIO STATION BED CONNECTOR; SYSTEM, COMMUNICATION, POWERED

Model Number P2505NNC1B00

Device Problem No Audible Alarm (1019)

Patient Problem Fall (1848)

Event Date 04/24/2022

Event Type  malfunction  

Event Description

Patient had unwitnessed fall.Patient was in bed with bed alarm on.Alarm sounded in patient room, but alarm did not sound at nurses station.Fda safety report id# (b)(4).

• Brand Name: ASBC, REV B AUDIO STATION BED CONNECTOR
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 14488527
• MDR Text Key: 292613253
• Report Number: MW5109865
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P2505NNC1B00
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White