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

Model Number ORG-9100A

Device Problem Device Operational Issue (2914)

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

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that two multiple patient receivers (org) power cycled unexpectedly and the telemetry cns showed communication loss.The orgs are connected to a ups along with other org devices.Bme states that the ups has clean power for all of the devices and all of the power outlets being used by all orgs are supported for ups.When the power cycle occurred with the two orgs, the other devices connected to the same ups were not affected.Generator power is also deployed behind the ups for extra backup.They have not had any power outages to his knowledge and the issue was isolated to the org closet.There are 8 orgs in total within the closet.Nihon kohden technical support (nkts) advised the bme to consider connecting one of the orgs to the wall directly and monitor it, as well as trying another upos in place of this one.Nkts asked the customer to double check that all of the power outlets on the ups are in fact clean power from the battery backup and not just pass through ac power.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 biomedical engineer (bme) reported that two multiple patient receivers (org) power cycled unexpectedly and the telemetry cns showed communication loss.

• 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, 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: 7010906
• MDR Text Key: 91466354
• Report Number: 8030229-2017-00392
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• 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: 11/08/2017

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2017
• Distributor Facility Aware Date: 10/11/2017
• Device Age: 95 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2017
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/08/2017
• Date Device Manufactured: 10/26/2010
• 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