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

Model Number ORG-9100A

Device Problem Device Inoperable (1663)

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

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the 4th and 5th receiver on the org is giving a low rssi resulting in signal loss.The device was sent in for evaluation and repair.The reported problem was duplicated.It was noted, that during the evaluation, the rest of the beds 1, 2, 3, and 6 have excessive noise on respiration and spo2 waveforms.All receivers were replaced with brand new receivers.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

Event Description

The customer reports that the 4th and 5th receiver on the org is giving a low rssi resulting in signal loss.

• 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: 5942083
• MDR Text Key: 54407042
• Report Number: 8030229-2016-00464
• 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
• Report Date: 09/11/2016,08/12/2016

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-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2016
• Distributor Facility Aware Date: 08/12/2016
• Device Age: 93 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2016
• Initial Date Manufacturer Received: 09/11/2016
• Initial Date FDA Received: 09/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2008
• 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