MAUDE Adverse Event Report: HILL-ROM BATESVILLE AFFINITY 4 BED FRAME; TABLE, OBSTETRIC (AND ACCESSORIES)

Model Number P3700E000039

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the head portion of an affinity 4 birthing bed raised on its own to the highest limit (sitting position) in the middle of a procedure.Follow up with the customer notes that the procedure occurring at the time of the event was suturing after birth.The customer additionally states the care team was not able to get the head of the bed back down for the duration of the procedure, however there was no injury to the patient or care team from the event.After the procedure, the patient was transferred to another bed.The customer states that a hillrom fst came to the facility and noted that parts needed to be ordered for device repair.The affinity birthing bed is intended to be used as a birthing bed for women of childbearing age in an ldr (labor, delivery, recovery) or ldrp (labor, delivery, recovery, postpartum) setting within the acute care labor and delivery market.It is not intended for use as a general hospital bed.The device instructions for use note the following on the head section: the head up/down controls located on both siderails enable you to raise or lower the head section of the bed.The head section can be raised to any angle of inclination up to 63 degrees.To raise¿press and hold the head up control to raise the head section of the bed.To lower¿press and hold the head down control to lower the head section of the bed.Note: the head up/down and bed up/down functions will not work at the same time.If you press the head up and bed up control, the bed will raise until you release the bed up control.The device ifu additionally notes the following on the cpr function ¿ identifies the release lever that can be used to manually drop the inclined head section, in order that cardiopulmonary resuscitation can be performed without delay.This function would have been possible to lower the head, however the device would have instantly raised again if the power cord remained plugged in.Inspection of the device by a hillrom technician found the siderail pc board was bad and has placed an order for the component.There was no injury or delay in care from the event, however hillrom is cautiously reporting this event due to the potential for serious injury if the reported failure of the head of the bed raising, and unable to be lowered, during an emergent and/or critical procedure, were to recur.Based on this information, no further action is required.

Event Description

It was reported that the head portion of an affinity 4 birthing bed raised on its own to the highest limit (sitting position) in the middle of a procedure.Follow up with the customer notes that the procedure occurring at the time of the event was suturing after birth.The customer additionally states the care team was not able to get the head of the bed back down for the duration of the procedure.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: AFFINITY 4 BED FRAME
• Type of Device: TABLE, OBSTETRIC (AND ACCESSORIES)
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15183127
• MDR Text Key: 298214809
• Report Number: 1824206-2022-00353
• Device Sequence Number: 1
• Product Code: KNC
• UDI-Device Identifier: 00887761000896
• UDI-Public: 010088776100089611180409
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3700E000039
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1