PRIMUSRS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-26 for PRIMUSRS * manufactured by Bte Technologies, Inc..

Event Text Entries

[21261830] Patient had just completed a continuous passive motion (cpm) activity with the bte equipment. The therapist was looking up the report with the total range when the head unlocked, dropping the tool in a downward arc. Patient was still in the machine at the time. The machine did not beep to indicate that it was going to unlock and the button you push to either unlock/lock the machine continued to display "unlock" indicating it needed to be pushed to unlock the machine. The patient was startled and complained of some discomfort over the radial aspect of the wrist around the thumb carpometacarpal joint. The machine is now marked out of service. The patient felt ok at the end of the session. The device also failed to boot-up properly then next time it was turned on. What was the original intended procedure? Hand therapy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2992449
• MDR Report Key: 2992449
• Date Received: 2013-02-26
• Date of Report: 2013-02-26
• Date of Event: 2013-01-30
• Report Date: 2013-02-26
• Date Reported to FDA: 2013-02-26
• Date Reported to Mfgr: 2013-03-07
• Date Added to Maude: 2013-03-07
• 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: 3
• Reporter Occupation: RISK MANAGER
• 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: PRIMUSRS
• Generic Name: EXERCISER
• Product Code: BXB
• Date Received: 2013-02-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BTE TECHNOLOGIES, INC.
• Manufacturer Address: 7455-L NEW RIDGE ROAD HANOVER MA * US *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-02-26