MAUDE Adverse Event Report: NIHON KOHDEN CORP ZM-920A; TELEMETRY TRANSMITTER

Model Number ZM-920PA

Device Problems Radiofrequency Interference (RFI) (2314); Device Operates Differently Than Expected (2913)

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

Event Date 05/01/2015

Event Type  malfunction  

Event Description

Customer stated that when they turn on the z-920pa telemetry transmitter, all other receivers that are monitored from the same org receiver show artifact.Mfr ref # 8030229-2015-00111.

• Brand Name: ZM-920A
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORP
• MDR Report Key: 4802830
• MDR Text Key: 5830414
• Report Number: 2080783-2015-00111
• 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: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-920PA
• Device Catalogue Number: ZM-920PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1