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

Model Number ORG-9100A

Device Problems Failure to Cycle (1142); Device Inoperable (1663)

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

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org has 2 receiver cards with the rssi values of 4.The customer has power cycled the org and the value remained at 4.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 that the org has 2 receiver cards with the rssi values of 4.The customer has power cycled the org and the value remained at 4.

Manufacturer Narrative

Manufacturer narrative: the customer reported that the org has 2 receiver cards with the rssi values of 4.The customer has power cycled the org and the value remained at 4.Power cycling the org resolved the issue.The rssi value was at 10.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.Device not returned.

• Brand Name: ORG-9100A
• Type of Device: MULTIPLE PATIENT RECEIVER
• 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; 486 nanokaichi; attn: shama mooman; gunma 370-2 343; JA 370-2343
• 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 ; 2687708
• MDR Report Key: 5365646
• MDR Text Key: 36275021
• Report Number: 8030229-2016-00017
• 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: 01/13/2016,12/23/2015

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: 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?: Yes
• Date Report Sent to FDA: 01/13/2016
• Distributor Facility Aware Date: 12/23/2015
• Device Age: 90 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2016
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 01/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2008
• 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