MIDLAND BARIATRIC STAND -IN TABLE 554512E *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-11 for MIDLAND BARIATRIC STAND -IN TABLE 554512E * manufactured by Patterson Medical.

Event Text Entries

[3866843] Pt was seated in wheelchair with 2 therapists present attempting to stand pt in bariatric standing frame. The frame was being lowered to the ground to lock into place and was lowered onto patient's left big toe. Pt reported pain and the stand was immediately lifted from toe. Therapist saw blood on sock. Two therapists present removed long stocking sock and grip sock, cleaned toe with wet cloth. Toe did not appear to be broken or severely injured. Follow-up investigation: witness had stated that this has happened before one time that he could remember. From the details related, the normal protocol is to have the stand in the lowered position before patient is attached, then secure and lift the patient. Apparently during this lift some readjustments were needed including moving the position of the stand. So the frame was raised and lowered again while patient was attached. This is when the injury occurred. Some discussion on design improvement was brought up. A couple of suggestions were to have the knee pad made adjustable to accommodate different shaped patients and some kind of guard to prevent toes from going under the frame. Maude database checked and one similar report was found. Recommendations from the manufacturer were apply a warning sticker on the machine advising to make sure lift is lowered position before lifting patient. The device in question had 2 of these on it. One by the handle that controls the raising and lowering of the frame and the other was on the back side of the stand. The ot unit only has one of these devices and it is needed for this patient so it was put back in use. Ot supervisor is going to work on additional labeling and education of staff to not raise the frame once a patient is secured to the stand. From conversation from staff they felt that this is both a use problem and a design issue. ====================== manufacturer response for standing frame, bariatric standing frame (per site reporter). ====================== recommendations from the manufacturer were apply a warning sticker on the machine advising to make sure lift is lowered position before lifting patient. The device in question had 2 of these on them.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3337685
• MDR Report Key: 3337685
• Date Received: 2013-08-11
• Date of Report: 2013-06-12
• Date of Event: 2013-06-12
• Report Date: 2013-06-12
• Date Reported to FDA: 2013-08-11
• Date Reported to Mfgr: 2013-09-10
• Date Added to Maude: 2013-09-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIDLAND BARIATRIC STAND -IN TABLE
• Generic Name: WHEELCHAIR, STANDUP
• Product Code: IPL
• Date Received: 2013-08-11
• Model Number: 554512E
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PATTERSON MEDICAL
• Manufacturer Address: 1031 MENDOTA HEIGHTS RD SAINT PAUL MN 55120 US 55120

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-08-11