MAUDE Adverse Event Report: ALPINE BIOMED ELECTRODE, CUTANEOUS

Model Number P334204DM33

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The health care professional reported the patient's unit was not working.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ELECTRODE, CUTANEOUS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): ALPINE BIOMED
• MDR Report Key: 17534090
• MDR Text Key: 321475028
• Report Number: MW5140993
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: P334204DM33
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1