MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. DINAMAP PROCARE 200; PHYSIOLOGICAL PATIENT MONITOR

Device Problem Arcing (2583)

Patient Problem Tingling (2171)

Event Date 02/01/2014

Event Type  Injury  

Event Description

The customer reports a research participant was sitting on a hospital bed with her bare feet on the floor.After the critikon dura-cuff (attached to the dinamap) was placed on the right arm of the participant, it was noted the device's low battery indicator came on.The dinamap was then plugged into a power strip that had been connected to the bottom of the bed.As the blood pressure measurement started, an arc of the power cord occurred.The subject experienced a hot sensation along with discomfort and tingling in the right arm and sustained a linear blemish to her right arm as well as ongoing tingling of the right hand.The device was then plugged into an alternate power source and the blood pressure was taken without an issue.

Manufacturer Narrative

Investigation revealed a defective electrical power strip was mounted to the metal bed frame by using a screw and plugged into the ac mains on the wall.The research participant was sitting on the bed with her bare feet on the floor and her arm must have been touching the bed frame, thereby creating an electrical path to the ground.When the battery charger from the procare monitor was plugged into the defective power strip, the power strip's internal circuit board was moved enough to cause an internal short from the mounting screw to the circuit board inside the power strip.There was an electrical arc on the power strip which caused the bed frame to become conductive and current to flow from the ac mains through the bed frame, to the subject's arm and to the ground through her feet.The procare monitor, cuff, hose, and battery charger do not have any electrical connection to the patient during blood pressure determinations.The materials making up these components are purely non-conductive insulating materials with no electrical or conductive components, thus there is no possible current flow through the cuff and hose assembly that is connected to the procare 200.The procare passed safety testing and was tested again while plugged into a different ac mains with no incident.The unit was returned to the leasing company where it was tested with no issues.

• Brand Name: DINAMAP PROCARE 200
• Type of Device: PHYSIOLOGICAL PATIENT MONITOR
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 0000 ; MX 0000
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 0000 ; MX 0000
• Manufacturer Contact: joy sonsalla ; 3000 n. grandview blvd; waukesha, WI 53188 ; 2625482661
• MDR Report Key: 3738601
• MDR Text Key: 4272486
• Report Number: 3008729547-2014-00005
• Device Sequence Number: 1
• Product Code: MWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other