MAUDE Adverse Event Report: HILL-ROM, INC AFFINITY III BIRTHING BED; TABLE, OBSTETRIC (AND ACCESSORIES)

Model Number P3700

Device Problems Device Inoperable (1663); Unintended Movement (3026)

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

Event Date 09/14/2017

Event Type  malfunction  

Event Description

Patient in labor and delivery department for labor.Head of patient's bed slightly higher than foot of bed due to birthing position.Father sat on the foot of the bed and the bed dropped to low position.Bed controls would not work.Patient was moved to new birthing bed.First bed tagged and sent to biomed for repair.Bed was repaired and now back on the unit.

• Brand Name: AFFINITY III BIRTHING BED
• Type of Device: TABLE, OBSTETRIC (AND ACCESSORIES)
• Manufacturer (Section D): HILL-ROM, INC; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6957451
• MDR Text Key: 89591064
• Report Number: 6957451
• Device Sequence Number: 1
• Product Code: KNC
• 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: Other
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3700
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2017
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2017
• 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
• Treatment: NO
• Patient Age: 21 YR
• Patient Weight: 69