MAUDE Adverse Event Report: NIHON KOHDEN CORP ZM-540PA; TELEMETRY TRANSMITTER

Model Number ZM-540PA

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

Customer stated the telemetry transmitter become abnormally hot and had a burning smell.Mfr ref#: 8030229-2015-00059.

• Brand Name: ZM-540PA
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORP
• Manufacturer (Section G): NIHON KOHDEN AMERICA, INC.; 90 icon st.; foothill ranch CA 92610 160
• Manufacturer Contact: 90 icon st.; foothill ranch, CA 92610-1601
• MDR Report Key: 4707637
• MDR Text Key: 18039143
• Report Number: 2080783-2015-00059
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/19/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-540PA
• Device Catalogue Number: ZM-540PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1