MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-920PA; TELEMETRY TRANSMITTER

Model Number ZM-920PA

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

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

Event Date 08/01/2012

Event Type  malfunction  

Event Description

The customer stated that the zm-920pa telemetry transmitter battery overheated and slightly melted the transmitter housing, transmitter was hot to the touch.Upon inspection by the biomed, they found that the plastic wrapping of the battery had been damaged and the right side negative battery contact of the transmitter was bent and appeared to be shorting the battery.The clinician admitted to the biomed at the time of the examination that the unit had been dropped prior to the incident.Negative mark.No patient injury.

• Brand Name: ZM-920PA
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION
• 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: 4385948
• MDR Text Key: 5266811
• Report Number: 2080783-2014-00123
• Device Sequence Number: 1
• Product Code: DRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/01/2012

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-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: 08/01/2012
• Device Age: 116 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2012
• 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