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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 Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2024
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that the heart rhythms from this telemetry transmitter (tele) are showing artifacts.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 fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6, b6 - b7, d10 concomitant medical device.Attempt #1 02/14/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 02/15/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 03/06/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station (cns) model: ni, sn: ni, device manufacturer date: ni, unique identifier (udi) #: ni, returned to nihon kohden: not returned.Multiple patient receiver (org) model: ni, sn: ni, device manufacturer date: ni, unique identifier (udi) #: ni, returned to nihon kohden: not returned.
 
Event Description
The biomedical engineer (bme) reported that the heart rhythms from this telemetry transmitter (tele) are showing artifacts.No patient harm was reported.
 
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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
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key18899291
MDR Text Key337803971
Report Number8030229-2024-04163
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 Biomedical Engineer
Type of Report Initial
Report Date 03/13/2024
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-530PA
Device Catalogue NumberZM-530PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/12/2024
Initial Date FDA Received03/13/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2021
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
CENTRAL NURSE'S STATION; MULTIPLE PATIENT RECEIVER
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