MAUDE Adverse Event Report: HILL-ROM, INC. AFFINITY® 4 BIRTHING BED; TABLE, OBSTETRIC (AND ACCESSORIES)

Model Number P3700E

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

During a delivery if a baby, there was a broken stirrup on the delivery bed.

• Brand Name: AFFINITY® 4 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: 15635756
• MDR Text Key: 302058443
• Report Number: 15635756
• Device Sequence Number: 1
• Product Code: KNC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P3700E
• 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: 09/30/2022
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White