RICHMAR RM2060 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-06 for RICHMAR RM2060 * manufactured by Rich-mar, Inc..

Event Text Entries

[3320272] Nurse applied the electrodes for electrotherapy treatment. At completion of procedure, patient appeared to have 1st degree burn on skin where the electrodes were placed. Staff felt patient leaned into electrodes putting undo pressure on electrodes. ======================manufacturer response for electrical stimulator, (brand not provided) (per site reporter). ======================manufacturer tested the equipment and could not find any problem with the equipment. ======================manufacturer response for electrical stimulator-2, (brand not provided) (per site reporter). ======================manufacturer retested the equipment and did not find any malfunction. What was the original intended procedure? Electrotherapy. Device #1is this a laboratory device or laboratory test? No. Device #2is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3030104
• MDR Report Key: 3030104
• Date Received: 2012-09-06
• Date of Report: 2012-09-06
• Date of Event: 2012-02-28
• Report Date: 2012-09-06
• Date Reported to FDA: 2012-09-06
• Date Reported to Mfgr: 2013-04-02
• Date Added to Maude: 2013-04-02
• 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
• 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 Sequence Number: 1

• Brand Name: RICHMAR
• Generic Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERA
• Product Code: IMG
• Date Received: 2012-09-06
• Returned To Mfg: 2012-02-28
• Model Number: RM2060
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: R
• Device Age: 14 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RICH-MAR, INC.
• Manufacturer Address: 4120 SOUTH CREEK ROAD CHATTANOOGA TN 37406 US 37406

Device Sequence Number: 2

• Brand Name: INTELECT LEGEND
• Generic Name: DIATHERMY, ULTRASONIC, FOR USE IN APPLYING THERAPEUTIC DEEP
• Product Code: IMG
• Date Received: 2012-09-06
• Returned To Mfg: 2012-02-28
• Model Number: XT-2760
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 2 YR
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: RICH-MAR, INC.
• Manufacturer Address: 4120 SOUTH CREEK ROAD CHATTANOOGA TN 37406 US 37406

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-09-06