MAUDE Adverse Event Report: HILL-ROM INC AFFINITY III; BIRTHING BED

Model Number AFFINITY III

Device Problems Collapse (1099); Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2015

Event Type  malfunction  

Event Description

Birthing bed positioned for patient for administration of epidural.Patient sitting at upper part of mattress and the bottom of bed collapsed to floor.Anesthesia and staff assisted patient standing position.No harm to patient or staff.

• Brand Name: AFFINITY III
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM INC; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 4755142
• MDR Text Key: 18069302
• Report Number: 4755142
• Device Sequence Number: 1
• Product Code: HDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: AFFINITY III
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2015
• Device Age: 20 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1