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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

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NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER Back to Search Results
Model Number ZM-530PA
Device Problems Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
The nurse reported that there were no alarms during a syncopal episode.Multiple events were not captured.There were multiple 3 second pauses not captured or alarming.The central nurse's station (cns) did not alarm and patient was found unresponsive with no pulse.There was no patient death, but the customer noted that it was a near miss.The medtronic (device) was able to capture them.No known impact or consequence to the patient.Concomitant medical products: the following device(s) were being used in conjunction with the telemetry transmitter, but model and serial number information was not provided for the multiple patient receiver and was noted as no information (ni), as attempts to obtain information were made but information was not provided.Central nurse's station: model: cns-6201a, (b)(4).Multiple patient receiver (org): model: ni, sn: ni.
 
Event Description
The nurse reported that there were no alarms during a syncopal episode.Multiple events were not captured.There were multiple 3 second pauses not captured or alarming.The central nurse's station (cns) did not alarm and patient was found unresponsive with no pulse.There was no patient death, but the customer noted that it was a near miss.No known impact or consequence to the patient.
 
Manufacturer Narrative
Details of complaint: the nurse reported there were no alarms exhibited at the central nurse's station (cns) for multiple syncopal episodes and the patient was found unresponsive with no pulse.The customer stated that this was a near miss.It was also noted that the medtronic device was able to capture the events.No patient harm or injury was reported.Investigation summary: there was no patient death.In the event description of the adverse event information form, it was indicated that the during a patient event the device did not alarm.The customer indicated that a medtronic device was able to capture the event.The logs were reviewed by nkc.There were many log entrees where it showed "signal loss" and "electrode off." additional information was requested from the customer, however, there was no response from the customer.The log investigation was inconclusive due to the lack of information.A review of the history of the serial number identified no similar events.Based on the available information, a definitive root cause could not be identified.Due to multiple logs of signal loss and electrode off error messages observed on the logs, possible causes of the issue are poor network environment, bad lead and electrode placement, bad lead and cables.
 
Event Description
The nurse reported there were no alarms exhibited at the central nurse's station (cns) for multiple syncopal episodes and the patient was found unresponsive with no pulse.No known impact or consequence to the patient.
 
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Brand Name
ZM-530PA
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 116-8 560
JA  116-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
attn: shama mooman
1-1 tajino
tomioka city, gunma 370-2 314
JA   370-2314
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key11202505
MDR Text Key244662539
Report Number8030229-2021-00014
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921115091
UDI-Public4931921115091
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberZM-530PA
Device Catalogue NumberZM-530PA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received01/20/2021
Supplement Dates Manufacturer Received03/02/2023
Supplement Dates FDA Received03/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CNS-6201A SN (B)(6); CNS-6201A SN (B)(6); MULTIPLE PATIENT RECEIVER; MULTIPLE PATIENT RECEIVER
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age73 YR
Patient SexFemale
Patient Weight87 KG
Patient RaceBlack Or African American
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