ORG-9110A
Report
- Report Number
- 8030229-2025-05477
- Event Type
- Malfunction
- Date Received
- September 18, 2025
- Date of Event
- August 22, 2025
- Report Date
- December 17, 2025
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- DRG
- UDI-DI
- 04931921103906
- PMA / PMN Number
- K071058
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS REPEATEDLY EXPERIENCING INTERMITTENT COMM LOSS. WHEN COMMUNICATION LOSS OCCURS, IT AFFECTS ALL INSTALLED RECEIVERS SIMULTANEOUSLY, LASTING ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING TESTING, THE REPORTED ISSUE OF INTERMITTENT COMMUNICATION LOSS COULD NOT BE DUPLICATED. AS SUCH, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DEFINITIVELY ESTABLISHED. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY BY SERIAL NUMBER REVEALS TWO PREVIOUS TICKETS, 198686 AND 221515. THE FORMER WAS RESOLVED BY INITIALIZING THE UNIT, AND THE LATTER WAS RESOLVED BY SOFTWARE REINSTALLATION AND INITIALIZATION. NIHON KOHDEN WILL CONTINUE TO TREND AND MONITOR. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 08/28/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 09/11/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 09/18/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. D9 DEVICE AVAILABLE FOR EVALUATION. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE?. H3 DEVICE EVALUATED BY MANUFACTURER. H6 EVENT PROBLEM AND EVALUATION CODES. H11 ADDITIONAL MANUFACTURER NARRATIVE.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS REPEATEDLY EXPERIENCING INTERMITTENT COMM LOSS. WHEN COMMUNICATION LOSS OCCURS, IT AFFECTS ALL INSTALLED RECEIVERS SIMULTANEOUSLY, LASTING ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED. 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. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 08/28/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 09/11/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 09/18/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS REPEATEDLY EXPERIENCING INTERMITTENT COMM LOSS. WHEN COMMUNICATION LOSS OCCURS, IT AFFECTS ALL INSTALLED RECEIVERS SIMULTANEOUSLY, LASTING ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS REPEATEDLY EXPERIENCING INTERMITTENT COMM LOSS. WHEN COMMUNICATION LOSS OCCURS, IT AFFECTS ALL INSTALLED RECEIVERS SIMULTANEOUSLY, LASTING ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2841442 | ORG-9110A | MULTIPLE PATIENT RECEIVER | DRG | NIHON KOHDEN CORPORATION | ORG-9110A | NA | 04931921103906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NI. |