inforMED
MalfunctionDRG

ORG-9110A

Received Dec 9, 2021 · Event occurred Nov 12, 2021

Report 8030229-2021-02109 · MDR key 12973264

Device

Generic name

Multiple Patient Receiver

Model number

ORG-9110A

Catalog number

ORG-9110A

Lot number

NA

Product problems

  • Application Program Problem
  • Communication or Transmission Problem
  • Application Program Problem
  • Communication or Transmission Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THE CENTRAL NURSE'S STATION (CNS) AND THE REMOTE NURSE'S STATION (RNS) EXPERIENCED COMMUNICATION LOSS (COMM LOSS) AND/OR ADMIT ISSUES. ACCORDING TO THE CUSTOMER, 5 TELES WILL NOT LET THEM ADMIT AND 1 IS IN COMM LOSS. PER THE CUSTOMER, THERE WERE 3 TELES THAT WOULD NOT ADMIT AND ONE THAT WAS IN COMM LOSS AT THE CNS. THE RNS SHOWED 2 TELES THAT WOULD NOT ADMIT. TECHNICAL SUPPORT (TS) SPOKE WITH BIOMED, A CHARGE NURSE AND A MONITOR TECH AND IT ALL CAME DOWN TO 4 TELES NOT BEING ABLE TO ADMIT. THE ISSUE WAS RESOLVED BY POWERING ONE ORG THAT HAD BEEN TURNED OFF AS THE POWER CABLE WAS DISCONNECTED. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: NK TECH SUPPORT ADVISED THE CUSTOMER TO CHECK THE ORG AND FOUND THAT THE ORG WAS POWERED OFF DUE THE POWER CABLE BEING DISCONNECTED. POWERING ON THE ORG RESOLVED THE ISSUE OF COMMUNICATION LOSS. THE ROOT CAUSE OF COMMUNICATION LOSS DUE TO UNCONNECTED CABLE IS USE ERROR. AS THERE IS NO EVIDENCE OF AN NK DEVICE MALFUNCTION, A CAPA IS NOT WARRANTED. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE ORG:, CNS:, MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NI. D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE ORG:, RNS:, MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NI. D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE ORG:, TRANSMITTERS:, MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NI. MANUFACTURER REFERENCES # 300274996 - 124977 FOLLOW UP 001.

Description of Event or Problem

THE CUSTOMER REPORTED THE CENTRAL NURSE'S STATION (CNS) AND THE REMOTE NURSE'S STATION (RNS) EXPERIENCED COMMUNICATION LOSS (COMM LOSS) AND/OR ADMIT ISSUES. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, 5 TELES WILL NOT LET THEM ADMIT AND 1 IS IN COMM LOSS. PER THE CUSTOMER, THERE WERE 3 TELES THAT WOULD NOT ADMIT AND ONE THAT WAS IN COMM LOSS AT THE CNS. THE RNS SHOWED 2 TELES THAT WOULD NOT ADMIT. TECHNICAL SUPPORT (TS) SPOKE WITH BIOMED, A CHARGE NURSE AND A MONITOR TECH AND IT ALL CAME DOWN TO 4 TELES NOT BEING ABLE TO ADMIT. THE ISSUE WAS RESOLVED BY POWERING ONE ORG THAT HAD BEEN TURNED OFF AS THE POWER CABLE WAS DISCONNECTED. 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. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE ORG: TRANSMITTERS: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NI.

Description of Event or Problem

THE CUSTOMER REPORTED THE CENTRAL NURSE'S STATION (CNS) AND THE REMOTE NURSE'S STATION (RNS) EXPERIENCED COMMUNICATION LOSS (COMM LOSS) AND/OR ADMIT ISSUES. THERE WAS NO PATIENT INJURY REPORTED.