MAUDE Adverse Event Report: HILL-ROM ADVANTA HOSPITAL BED

Device Problem Collapse (1099)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Hyperventilation (1910); Incontinence (1928); Renal Failure (2041); Tachycardia (2095)

Event Date 11/26/2015

Event Type  Injury  

Event Description

The (b)(6) male patient was admitted to the hospital over a month ago for issues with bleeding in the bladder.He underwent at least two surgical procedures to control/stop the bleeding.On (b)(6) 2015, two days after his last surgery, the patient was sitting up in bed.He asked his wife to lower the head of the bed and the bed collapsed, slamming his head down very hard.The patient has a history of copd.His wife called the nursing staff and they tried to raise the head of the bed.The bed would not work to raise the head.The staff left the patient's wife alone in the room while they tried to find a replacement bed.During this time, the patient's wife was trying to hold his head up and keep his head elevated with pillows as he was experiencing breathing problems.Due to this and severe abdominal pain from the bed collapse, the patient lost control of his bowels.In addition, he started hyperventilating and experienced a rapid heart beat.The patient was transferred to intensive regained consciousness and there is evidence of impaired kidney function.At this time, his prognosis is not good and the hospital has encouraged the patient's wife to "pull the plug".The patient was transferred to the intensive care unit of another hospital on (b)(6) 2015 for care with his treating pulmonary physician.

• Brand Name: ADVANTA HOSPITAL BED
• Type of Device: ADVANTA HOSPITAL BED
• Manufacturer (Section D): HILL-ROM
• MDR Report Key: 5274051
• MDR Text Key: 32982250
• Report Number: MW5058366
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 70