MAUDE Adverse Event Report: PROTOUCH MDDS/EHR DEVICE

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2014

Event Type  Injury  

Event Description

Complex case with multi organ failure was on high doses of potassium supplements and potassium sparing medications.The potassium level obtained in the lab and electronically sent to the dhr mdds had increased from 4.0 to 4.9 mg% over a 24 hour period of tome.The nurses were not alerted by the mdds of new results, nor did they open the mdds to check the interval change of the potassium level prior to administering 40 meq potassium chloride twice.This points out the defect in the mdds, which is its failure to notify of new results and provide meaningfully useful decision support.These devices are not safe and require oversight.

• Brand Name: MDDS/EHR DEVICE
• Type of Device: MDDS
• Manufacturer (Section D): PROTOUCH; louisville 40202
• MDR Report Key: 3955740
• MDR Text Key: 16450048
• Report Number: MW5037372
• Device Sequence Number: 1
• Product Code: NSX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Weight: 103