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

Model Number ORG-9700A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org was in signal loss on multiple tele devices.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 was in signal loss on multiple tele devices.No consequence or impact to patient.

Event Description

The customer reported that the org was in signal loss on multiple tele devices.No consequence or impact to patient.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018 customer reported that 9 to 12 beds on the cns were showing communication loss.Customer was not near the cns to provide details regarding these beds.Customer later called back to update that one org receiver (mu-970ra s/n (b)(6)) was causing the communication loss issue.Customer resolved the issue by replacing the org receiver.Notes on this record shows the org failed after the facility experienced a power issue.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: org receiver was put into service on 4/6/2006.Service history for this device shows no other service notifications.As documented, the org receiver failed after a facility power issue, thus it is concluded that facility power issue caused org failure.Review of the device history record (dhr) shows that the unit has no history of ncmr, refurbishing, or other suspected defects.Investigation conclusion as documented, the org receiver failed after a facility power issue, thus it is concluded that facility power issue caused org failure.Corrected information: f9.Approximate age of device: incorrectly calculated.Additional information: b4.Date of this report; 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; correction; h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.

• 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: 8070695
• MDR Text Key: 127874153
• Report Number: 8030229-2018-00423
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2020
• Distributor Facility Aware Date: 01/13/2020
• Device Age: 156 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2020
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1