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

Model Number ORG-9101A

Device Problems False Alarm (1013); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org malfunctioned.The org is giving random duplicate channel alarms on tele 64.No external sources were found to cause this alarm.They are random in occurrence and once cleared with the alarm silence, may not happen again for 10-20 minutes.Currently waiting for the customer to return their device for evaluation.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 malfunctioned.The org is giving random duplicate channel alarms on tele 64.No external sources were found to cause this alarm.They are random in occurrence and once cleared with the alarm silence, may not happen again for 10-20 minutes.

Manufacturer Narrative

The customer reported that the org malfunctioned.The org is giving random duplicate channel alarms on tele 64.No external sources were found to cause this alarm.They are random in occurrence and once cleared with the alarm silence, may not happen again for 10-20 minutes.The unit was cleaned and evaluated.The reported problem of duplicated channel on tele 64 ch-374 was not duplicated, however the evaluation found excessive noise on spo2 waveforms.All malfunctioning parts have been replaced.The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 120 hours of extended testing and operates to manufacturer's specifications.The device has been repaired and returned to the customer.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ORG-9110A
• 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; 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: 5892651
• MDR Text Key: 52618881
• Report Number: 8030229-2016-00415
• 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: 08/20/2016,07/21/2016

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-9101A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2016
• Distributor Facility Aware Date: 07/21/2016
• Device Age: 53 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2016
• Initial Date Manufacturer Received: 08/20/2016
• Initial Date FDA Received: 08/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2012
• 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