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

Model Number ZM-540PA

Device Problem Overheating of Device (1437)

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

Event Date 03/23/2012

Event Type  malfunction  

Event Description

Customer stated that the batteries installed incorrectly and the transmitter has been damaged.Damage is described as the plastic housing of the battery compartment appears melted.Mfr ref # 8030229-2014-00120.

• 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: 4391002
• MDR Text Key: 5432364
• Report Number: 2080783-2014-00120
• Device Sequence Number: 1
• Product Code: DRT
• 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: 03/23/2012

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-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: 03/23/2012
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2012
• 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