MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; BED, MANUAL

Model Number P1190A000082

Device Problem Collapse (1099)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

It was reported that a patient was reaching for a blanket at the foot section of the advanta 2 bed while the bed was in chair position when a weld on the bed broke causing the patient to fall.The patient sustained a hematoma and abrasions to the forehead.The patient was monitored but did not require any treatment for the reported injuries.This event was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

It was initially reported that a patient was reaching for a blanket at the foot section of the advanta 2 bed while the bed was in chair position when a weld on the bed broke causing the patient to fall.The patient sustained an unspecified head injury, but no additional details were provided.The following additional information was obtained from the manager of the progressive care unit where the reported event occurred.The male patient in this event was reported to be in his 50's and weighed 314 lb.The patient¿s admitting diagnosis and medical history was unknown.The reported event occurred at night on (b)(6) 2023.The advanta bed was in the chair/seated position and the footboard was installed on the bed.The patient reached towards his feet for a blanket when he heard a snapping sound from the bed and the patient was ¿ejected¿ out of the bed towards the foot of the bed and onto the floor.The patient sustained a hematoma and abrasions to his forehead.X-ray and ct scan were negative.The patient was monitored but did not require any treatment for his injuries.The patient was discharged home on (b)(6) 2023.The advanta¿ 2 bed is intended to provide patient support for low to moderate acuity patients in the medical/surgical area of the hospital.Per the device instructions for use, the maximum safe working load is 500 lb.The hillrom service technician inspected the bed and noted broken ends at the foot section and a broken right side slide bearing.The bed was repaired.A pm search was performed on this serial number resulting in no pm records found for this serial number.An abrasion is a wound that is no deeper than the epidermis and is less severe than a laceration, and bleeding if present is minimal.Mild abrasions do not scar or bleed.A hematoma is an injury to tissues with skin discoloration and without breakage of skin.Blood from the broken vessels accumulates in surrounding tissues, which may produce pain, swelling, and tenderness, and the discoloration is the result of blood seepage just under the skin.Most hematomas heal without treatment, but cold compresses may reduce bleeding if applied immediately after the injury, and thus may reduce swelling, discoloration, and pain.In this event, the patient did not sustain permanent impairment of a body function or permanent damage to a body structure and did not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes no serious injury occurred.However, if the reported event were to recur, it is likely to cause or contribute to a death or serious injury.Based on this information no further actions are required.

• Brand Name: ADVANTA 2 FRAME
• Type of Device: BED, MANUAL
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16428254
• MDR Text Key: 310238861
• Report Number: 3006697241-2023-00015
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P1190A000082
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Male
• Patient Weight: 142 KG