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

Model Number ORG-9110A

Device Problems No Display/Image (1183); Radio Signal Problem (1511); Invalid Sensing (2293); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the org experienced signal loss on multiple channels and had spikes on the spo2 waveform.It was confirmed that the revision of the receivers was too low and should be upgraded from rev ad to rev af or higher to resolve the issue.The unit was in use on patients, but no patient harm was reported.The biomedical engineer sent the unit in for repair and it is currently awaiting evaluation.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The biomedical engineer reported that the org experienced signal loss on multiple channels and had spikes on the spo2 waveform.

Manufacturer Narrative

Corrected data: device evaluated by manufacturer, additional manufacturer narrative, additional information: type of report? follow up, type of report follow up, additional information/correction, event problem and evaluation codes.The biomedical engineer reported that the org experienced signal loss on multiple channels and had spikes on the spo2 waveform.It was confirmed that the revision of the receivers was too low and should be upgraded from rev ad to rev af or higher to resolve the issue.The unit was in use on patients but no patient harm was reported.The biomedical engineer sent the unit in for repair and the unit has been evaluated.The reported problem of spikes on the spo2 waveform and disappearing values were duplicated.All malfunctioning parts were replaced.The unit was tested per the operator's/service manual and the unit completed 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; 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; JA 359-8580
• MDR Report Key: 6715056
• MDR Text Key: 80081593
• Report Number: 8030229-2017-00232
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• 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: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 07/14/2017
• Distributor Facility Aware Date: 06/16/2017
• Device Age: 58 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2017
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2012
• 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