MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; RECEIVER UNIT

Model Number ORG-9110A

Device Problems Device Stops Intermittently (1599); Radiofrequency Interference (RFI) (2314); Wireless Communication Problem (3283)

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

Event Date 08/13/2012

Event Type  malfunction  

Event Description

The customer stated that the org-9110a receiver has problem with noise on four of their receiver slots.Mfr ref #8030229-2014-00128.

• Brand Name: ORG-9110A
• Type of Device: RECEIVER UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION
• MDR Report Key: 4385994
• MDR Text Key: 5262334
• Report Number: 2080783-2014-00128
• 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: 09/08/2014,08/13/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/13/2012
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1