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

Model Number ORG-9700A

Device Problems Device Alarm System (1012); Device Issue (2379); Device Displays Incorrect Message (2591)

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

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported the org has an error light.They tried to initialize the device, but the error code continued.The issue was discovered when the customer attempted to transfer the patient.The customer was advised the org is obsolete and may not be repairable.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reported the org has an error light.They tried to initialize the device, but the error code continued.The issue was discovered when the customer attempted to transfer the patient.

Manufacturer Narrative

Manufacturer narrative: the customer reported the org has an error light.They tried to initialize the device, but the error code continued.The issue was discovered when the customer attempted to transfer the patient.The customer was advised the org is obsolete and may not be repairable.Device was sent in and evaluated.The reported complaint was confirmed.The mother board was changed to fix this issue.The rssi levels were tested prior to shipping.All receivers were working correctly.Device was repaired and returned.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• 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, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; 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 ; 2687488
• MDR Report Key: 5780671
• MDR Text Key: 49831174
• Report Number: 8030229-2016-00298
• 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,Followup
• Report Date: 07/08/2016,06/08/2016

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: ORG-9700A
• Device Catalogue Number: MU-970RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2016
• Distributor Facility Aware Date: 06/08/2016
• Device Age: 121 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2016
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 07/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2006
• 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