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

Model Number P3700B000010

Device Problem Collapse (1099)

Patient Problem Neck Pain (2433)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating a patient was positioned on an affinity bed at the highest elevated setting when the bed ¿suddenly collapsed to the lowest setting rather than gently descending¿ when the nurse pressed the button to lower the bed.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

It was reported that following an epidural placement, a patient was positioned on an affinity bed at the highest elevated setting when the bed ¿suddenly collapsed to the lowest setting rather than gently descending¿ when the nurse pressed the button to lower the bed.The patient had ongoing mild neck and back pain following the event.The providers physically assessed the patient and medical imaging was offered to which the patient declined.Nursing utilized heat pads and anti-inflammatory medications were ordered to address the pain.The patient is a 29-year-old female with a bmi of 31.52 who was admitted for pregnancy.The customer technician suspected a high/low motor failure, and the device was pulled from use and stored in the customer¿s on-site bed shop for inspection by a hillrom technician.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.Inspection of the device by a hillrom technician found the customer had the cover to all the electronics open and repairs in progress.The technician notes he found the bed in the highest position and was unable to get the bed to raise or gain access to the underside of the bed.A visual inspection did not reveal any obvious damage or malfunction to the high/low cylinders.It was additionally noted this bed is not under warranty or under contract and any repairs by hillrom would ¿fee for service¿ (ffs).The customer has ordered a high/low motor and plans to repair bed themselves.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.Pain and/or discomfort may be a symptom due to preexisting injury contained to a discrete area or a symptom felt more diffusely due to disorder or disease; however, pain and/or discomfort is not an injury of itself, however, it is an unpleasant sensation that typically stops once the stimulus is removed, is not life-threatening and does not require medical or surgical intervention to preclude permanent impairment of a body function or body structure.For this event, the patient had mild neck and back pain.Medical imaging was denied by the patient; however anti-inflammatory medications and a heating pad were utilized to address her pain.The patient experienced transient, mild discomfort that was not life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure and there was no need for medical or surgical intervention beyond the minor pain relief options offered, indicating a serious injury did not occur.However, if the malfunction (bed collapse) were to recur, it is likely to cause or contribute to serious injury or death.Therefore, ¿hillrom considers this complaint reportable.The account confirmed they repaired the bed by replacing the high/low motor.Based on this information, no further action is required.

• 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: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16325844
• MDR Text Key: 309154097
• Report Number: 1824206-2023-00060
• Device Sequence Number: 1
• Product Code: KNC
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3700B000010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2009
• 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
• Patient Age: 29 YR
• Patient Sex: Female