MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A; RECEIVER UNIT

Model Number ORG-9700A

Device Problems Communication or Transmission Problem (2896); Device Operational Issue (2914)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org has communication loss with the cns.The customer received a loaner and confirmed that each channel on the org was working.There was no harm reported.The org was returned to nihon kohden and is pending 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 customer reported that the org has communication loss with the cns.

Event Description

The customer reported that the org has communication loss with the cns.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018, customer stated that all bedside and org devices were in complete communication loss with the monitoring cns (mu-970ra serial number: (b)(6).The cns was sent back to nka for evaluation.The reported issue out communication loss could not be duplicated on the cns.Service requested: repair.Service performed: evaluation.Investigation result: no issues were found with the cns when evaluated at nka.Device was put into service on 5/9/2008.Service history shows no other incidents.Service history for this customer shows no similar incidents.Due to limited information available, the root cause could not be determined.Additional information: b4.Date of this report.D11.Concomitant medical products.E3.Occupation.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.Device evaluation.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.D11.Concomitant medical products: the cns was in conjunction with the transmitter.No model/serial provided.

• Brand Name: ORG-9700A
• Type of Device: RECEIVER UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7515658
• MDR Text Key: 108365755
• Report Number: 8030229-2018-00154
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

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-9700A
• Device Catalogue Number: MU-970RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2019
• Distributor Facility Aware Date: 10/07/2019
• Device Age: 124 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2019
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: CNS. NO MODEL/SERIAL