MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A; RECEIVER UNIT

Model Number ORG-9700A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that there was intermittent communication loss on their org (multiple patient receiver) unit.The customer states that the org was in intermittent communication loss that lasted five minutes.Nihon kohden technical support (nk/ts) instructed the customer to write down the ip address and verify the ip sticker on the org to match the unit.The customer mentioned that the communication loss is only with this org.After power cycling the org, it began to operate normally.

Event Description

The customer reported that there was intermittent communication loss on their org (multiple patient receiver) unit.

• Brand Name: ORG-9700A
• Type of Device: RECEIVER UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 7001462
• MDR Text Key: 91226171
• Report Number: 8030229-2017-00389
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9700A
• Device Catalogue Number: MU-970RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2017
• Distributor Facility Aware Date: 10/04/2017
• Device Age: 151 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2017
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1