MAUDE Adverse Event Report: NIHON KOHDEN CORP UNK ORG MODEL; TELEMETRY TRANSMITTER

Model Number UNK ORG MODEL

Device Problem Failure to Transmit Record (1521)

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

Event Date 04/10/2015

Event Type  malfunction  

Event Description

Customer stated that the zm-531pa transmitter displays a resp value that greatly differs from what the central monitoring system shows.Mfr ref #: 8030229-2015-00079.

• Brand Name: UNK ORG MODEL
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORP
• MDR Report Key: 4762281
• MDR Text Key: 5795119
• Report Number: 2080783-2015-00079
• 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: 04/10/2015

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: UNK ORG MODEL
• Device Catalogue Number: UNK ORG MODEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1