MAUDE Adverse Event Report: GENDRON BED, MANUAL

Model Number GENDRON MAXIREST BED

Device Problem Mechanical Problem (1384)

Patient Problem Fall (1848)

Event Date 08/08/2018

Event Type  malfunction  

Event Description

After i received a kpmsg from kaiser stating" please have technician gp check bed also carerail if tuned off as pt has fallen off bed.Pls deliver a trapeze also." i called and spoke with (b)(6) , pt daughter, advised her of the joerns protocol to pick up the equipment and have another set, bedframe and mattress placed.She refused the pick up of the gendron bedframe.She started there is nothing wrong with the equipment.It was the way it is set up and that the dflal, when inflated, rises to about 1 1/2" for the top of the rails.She believes that is why he fell out because the rails are not tall enough.She did request a replacement mattress, a specialty non powered mattress.I have been in contact with (b)(6) , the nursing supervisor at kaiser.I provided her the promatt plus non powered mattress code e0373.(b)(6) also inquired about the railing, she stated that there are only two top rails and non on the foot end, she believes that was a cause of the fall as well.The pt was not injured and sought no medical attention after the fall.She is very upset with kaiser for many reasons and stated if you need to speak with her to please call her today because she is leaving the country tomorrow at 6:00 am.She does not want anyone to bother her 90 years old parents and if a call must be made after today, please call the caregiver (b)(6) at (b)(6).Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, MANUAL
• Type of Device: BED, MANUAL
• Manufacturer (Section D): GENDRON
• MDR Report Key: 17528245
• MDR Text Key: 321463717
• Report Number: MW5135176
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: GENDRON MAXIREST BED
• Patient Sequence Number: 1
• Patient Age: 89 YR