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

Model Number ORG-9110A

Device Problems Failure to Read Input Signal (1581); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multiple patient receiver, org has signal loss on three telemetry devices.The signal strength with power on was 15 and with power off was 4, 6, and 8.A power cycle did not fix the issue.Customer would like to send the device in for evaluation.A loaner device was sent to the customer.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 multiple patient receiver, org has signal loss on three telemetry devices.

Manufacturer Narrative

The customer reported that the multiple patient receiver, org has signal loss on three telemetry devices.The signal strength with power on was 15 and with power off was 4, 6, and 8.A power cycle did not fix the issue.Customer sent in the device for evaluation.The reported problem of "signal loss on 3 tele" was duplicated, and the evaluation done by nihon kohden also found 4 other receivers having a spike on the spo2 waveform display.All malfunctioning parts were replaced.The unit was tested per operator's/service manual and the unit completed 24 hours of extended testing and operates to manufacturer's specifications.

• 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; 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 ; 2687488
• MDR Report Key: 6620791
• MDR Text Key: 77287860
• Report Number: 8030229-2017-00177
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• 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: 06/07/2017,05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/07/2017
• Distributor Facility Aware Date: 05/17/2017
• Device Age: 55 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2017
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2012
• 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