MAUDE Adverse Event Report: HILL-ROM, INC. HILL-ROM VERSACARE A.I.R. BED; BED, FLOTATION THERAPY, POWERED

Model Number P3200

Device Problem Defective Alarm (1014)

Patient Problems Fall (1848); Injury (2348)

Event Date 09/20/2019

Event Type  malfunction  

Event Description

Following a patient fall that resulted in injury, it was identified that the bed alarm was not working.Upon further examination by the biomedical technician, the bed alarm sound board stopped working resulting in the alarm not functioning as designed.There was no visible damage to the board, no cracks or problem noted.The manufacturer was contacted for support in repair/replacement.The installation date of the unit was march 25, 2014.Fda safety report id (b)(4).

• Brand Name: HILL-ROM VERSACARE A.I.R. BED
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN 47006
• MDR Report Key: 9540634
• MDR Text Key: 173951791
• Report Number: MW5092005
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• 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: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P3200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 70