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

Model Number P3700B000010

Device Problem Unintended Movement (3026)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

The bed was tested, and no issues were found; the hilo was working properly.As a precaution, the customer replaced the hydraulic motor, and the bed was put back in service.No further issues had been reported with the bed since the event occurred in (b)(6) 2020.Follow-up information was obtained from the facilitys risk manager as well as the claims manager who is managing this case.It was clarified that the reported event occurred on (b)(6) 2020 and involved a (b)(6) year-old who was in active labor.The head of the bed was up, the foot section was down, and the patient was in stirrups when the bed spontaneously dropped from its highest position to its lowest position.Hospital staff was present in the room and witnessed the event.The patient was the only one in the bed and no bed alarm was heard.Although the patients weight was unknown, the patient was described as tall but not obese.The patient had no immediate pain or symptoms when the bed dropped but was worried about low back pain because of an old basketball injury she sustained to her lower back when she was (b)(6).The patient was discharged from the hospital on (b)(6) 2020.At home, days later, the patient began experiencing pelvic pain, tightness in her mid-upper back and neck, headache, and her vision was not right.The patient reported these symptoms to her physician at her post-partum follow-up visit.A month later the patient had a huge bruise in the middle of her back.An mri was performed due to her symptoms, and physical therapy and chiropractic services were recommended based on mri results.The patient attended physical therapy services (duration not reported) but eventually required surgical intervention for left c6 radiculopathy and c5-c6 pulposus.The patient had a c5-c6 disc arthroplasty on (b)(6) 2021.Both reporters confirmed the affinity bed was taken out of service the day after the reported event and was inspected by the hospitals electronic technician who could not reproduce the reported problem.Per the claims manager, the hospital technician reported the bed did not sound right, further described as squeaking, and the pneumatic motor was replaced.No further information provided.The affinity 4 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 intended users of this product are healthcare employees who have been trained to use the product, and who have the physical strength and cognitive skills to operate and control the product.There are some controls and features on the bed intended to be used by the patients and family members upon appropriate orientation by the caregiver.The bed was inspected by the hillrom service technician on 15sep2021, and no issues were found with the hi-lo or any other part of the bed.Although the bed was found to function as designed at the time it was inspected by hillrom, the alleged malfunction cannot be ruled out as it was witnessed by hospital staff and the pneumatic motor was replaced by the hospital technician.Therefore, hillrom considers this a reportable malfunction for self-movement of the bed and a reportable serious injury.The affinity¿ 4 birthing bed requires an effective maintenance program.We recommend that you do annual preventive maintenance (pm) for joint commission certification.Pm not only meets joint commission requirements but can help make sure of a long, operative life for the affinity¿ 4 birthing bed.Two effective ways to reduce downtime and make sure the patient remains comfortable are to keep accurate records and maintain the affinity¿ 4 birthing bed.Check the switches in the side rails to ensure they are functioning correctly.Also check for intermittent operation.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.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the affinity birthing bed allegedly fell from high to low with a patient in the bed resulting in an unspecified patient injury.The reported event occurred in (b)(6) 2020 and the bed was taken out of service at that time and inspected by the customer.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).

• 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: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 12594142
• MDR Text Key: 275497078
• Report Number: 1824206-2021-00498
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3700B000010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2008
• 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 Outcome(s): Other