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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER
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NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER Back to Search Results
Model Number ZM-521PA
Device Problems Display or Visual Feedback Problem (1184); Application Program Problem: Dose Calculation Error (1189); Communication or Transmission Problem (2896); Output Problem (3005); Intermittent Communication Failure (4038)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
The customer reported that their multi-gas unit was displaying "cal error" alarms.The device also displayed "gas unspecified accuracy," and the customer reported the co2 reading to be about half of what it should have been.The customer tried changing the water trap and dry line, but the issue remained.He replaced the unit with another backup on hand.The customer received a loaner device and is sending in the defective device for repair.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.
 
Event Description
The customer reported that their multi-gas unit was displaying "cal error" alarms.The device also displayed "gas unspecified accuracy," and the customer reported the co2 reading to be about half of what it should have been.
 
Event Description
The customer reported that the telemetry transmitters on two floors went into comm loss at the central nurse's station (cns) and the remote network station (rns).
 
Manufacturer Narrative
Details of complaint: the customer reported that the telemetry transmitters on two floors went into signal loss at the central nurse's station (cns) and the remote network station (rns).No patient harm or injury was reported.Investigation summary: as the reported device was not returned for evaluation, a root cause cannot be determined.On-site support was sent to the customer responding to a different complaint to rebalance the antenna system to resolve the issue.A complaint history review of the customer's account reveals additional complaint reporting of signal loss.These events were reported to be intermittent.As such, it is likely that the signal loss was caused by environmental factors that interfere with wmts frequencies.There is no evidence that a nihon kohden device malfunctioned.
 
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Brand Name
ZM-521PA
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
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 Key9541697
MDR Text Key194500851
Report Number8030229-2020-00759
Device Sequence Number1
Product Code DRT
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/02/2020,02/15/2023
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 NumberZM-521PA
Device Catalogue NumberZM-521PA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/02/2020
Distributor Facility Aware Date12/09/2019
Device Age88 MO
Event Location Hospital
Date Report to Manufacturer01/02/2020
Initial Date Manufacturer Received 12/09/2019
Initial Date FDA Received01/02/2020
Supplement Dates Manufacturer Received01/13/2023
Supplement Dates FDA Received02/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2018
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; ORG; RNS
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