MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-930PA; TELEMETRY TRANSMITTER

Model Number ZM-930PA

Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

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

Event Date 03/19/2014

Event Type  malfunction  

Event Description

The customer stated that they were experiencing signal loss from 3 transmitters.Mfr ref #8030229-2014-00129.

• Brand Name: ZM-930PA
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION
• MDR Report Key: 4386001
• MDR Text Key: 15314486
• Report Number: 2080783-2014-00129
• Device Sequence Number: 1
• Product Code: DRG
• 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: Other
• Type of Report: Initial
• Report Date: 03/27/2014,03/19/2014

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-930PA
• Device Catalogue Number: ZM-930PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1