MAUDE Adverse Event Report: HILL-ROM, INC. HILL ROM BED WITH BUILT IN SCALE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1900

Device Problems Material Twisted/Bent (2981); Noise, Audible (3273)

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

Event Date 02/28/2020

Event Type  No Answer Provided  

Event Description

Patient laying quietly in bed.Patient pressed the electronic hand control to raise the head of the bed.Bed made a grinding noise and then the head of the bed twisted.No injury to patient.We notified the manufacturer, hill-rom.Manufacturer came on-site and took the defective bed away.Fda safety report id# (b)(4).

• Brand Name: HILL ROM BED WITH BUILT IN SCALE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 10628440
• MDR Text Key: 210175162
• Report Number: MW5097058
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: P1900
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 68