MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; RECEIVER UNIT

Model Number ORG-9100A

Device Problem Device Stops Intermittently (1599)

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

Event Date 08/07/2014

Event Type  malfunction  

Event Description

Customer is stating that they are having intermittent signal loss on the three org receivers and the telemetry transmitters on the floor.Mfr ref # 8030229-2014-00043.

• Brand Name: ORG-9100A
• Type of Device: RECEIVER UNIT
• 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: 4143715
• MDR Text Key: 4930579
• Report Number: 2080783-2014-00043
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1