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

Model Number ORG-9100A

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Wireless Communication Problem (3283)

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

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

The bme reported that the org gave a sawtooth waveform on multiple devices.Five follow-up attempts were made to the customer for additional information, however no further information was made available to nihon kohden on the event.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 reported that the org gave a sawtooth waveform on multiple devices.

• Brand Name: ORG-9100A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer Contact: susan shadley ; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687133
• MDR Report Key: 6298977
• MDR Text Key: 66459029
• Report Number: 8030229-2017-00019
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• 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: 02/02/2017,01/04/2017

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?: No
• 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: 02/02/2017
• Distributor Facility Aware Date: 01/04/2017
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2017
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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