MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TELEMETRY TRANSMITTER

Model Number ZM-520PA

Device Problem Overheating of Device (1437)

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

Event Date 04/23/2013

Event Type  malfunction  

Event Description

Customer stated that the plastic has melted in the battery compartment area.No patient injury occurred.Ref mfr report 8030229-2014-00119.

• Brand Name: ZM-520PA
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION
• MDR Report Key: 4391000
• MDR Text Key: 5432363
• Report Number: 2080783-2014-00119
• 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: 04/23/2013

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-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2013
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2013
• 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