MAUDE Adverse Event Report: HILL-ROM INDUSTRIES AFFINITY THREE; TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)

Model Number P3700

Device Problem Unintended System Motion (1430)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2015

Event Type  malfunction  

Event Description

Patient was attempting to sit up at edge of bed to have epidural catheter removed.Patient had baby in arms and was getting ready to hand baby to nurse (myself) when lower end of labor bed fell.Patient was hit with lower end of bed on her buttock area but did not fall on the floor.Patient was on her feet after lower end of bed fell and i had the baby and handed baby to the father of the baby.Patient was ambulatory and standing while i placed lower portion of labor bed in place and patient then ambulated to bathroom to void, change gown and pericare with no complaints.Patient then ambulated back to bed and lay in bed with no complaints.Bed reported to engineering for evaluation.Manufacturer response for hospital bed, birthing, affinity p3700 (per site reporter): manufacturer contacted to investigate and provide follow up.

• Brand Name: AFFINITY THREE
• Type of Device: TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)
• Manufacturer (Section D): HILL-ROM INDUSTRIES; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 5418703
• MDR Text Key: 37733516
• Report Number: 5418703
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P3700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR