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

Model Number 3700

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 05/15/2012

Event Type  Injury  

Event Description

Hill-rom received a report from the patient's attorney stating the bed moved during delivery of the patient's baby and the doctor fell on the patient.This caused the patient's legs to fall off the calf supports and the patient was injured.The bed was located in the labor and delivery department of the hospital.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

Hill-rom was notified of this issue from the patient's attorney 34 months after it occurred.No serial number for the bed was provided.This hospital indicates there is no record of the allegation of an injury or a malfunction of the bed.Due to the litigation in relation to this incident, hill-rom is not able to contact the patient directly.Additional information cannot be obtained at this time.Therefore, the severity of the alleged injury cannot be determined.If any additional relevant information is obtained, the additional information will be submitted in a supplemental report.

• Brand Name: AFFINITY THREE BED
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 4685505
• MDR Text Key: 18925851
• Report Number: 1824206-2015-00480
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1