MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Model Number ZM-521PA

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 10/14/2019

Event Type  malfunction  

Event Description

Patient was connected to a nihon kohden telemetry transmitter.Patient claimed the transmitter delivered her a shock.

• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 15353 barranca parkway; irvine CA 92618
• MDR Report Key: 9488645
• MDR Text Key: 171827618
• Report Number: 9488645
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/21/2019

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?: Yes
• Device Operator: No Information
• Device Model Number: ZM-521PA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1