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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER
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NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER Back to Search Results
Model Number ZM-531PA
Device Problems No Device Output (1435); Contamination /Decontamination Problem (2895); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2023
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the telemetry transmitter was not recording any vitals or readings at the central nurse's station (cns) or on the device itself.There were no error messages displayed.No patient harm was reported.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the telemetry transmitter was not recording any vitals or readings at the central nurse's station (cns) or on the device itself.There were no error messages displayed.Technical support (ts) had the bme replace the transmitter with a working one to continue patient monitoring activities.After further troubleshooting, ts was able to determine that the problem followed the transmitter.Bme confirmed there was no physical damage or fluid intrusion to the unit.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 contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6, b6, b7.Attempt # 1: (b)(6) 2023 emailed the bme for the patient information and the concomitant medical devices: no reply was received.Attempt # 2: (b)(6) 2023 emailed the bme for the patient information and the concomitant medical devices: the bme responded with the concomitant medical devices, but the patient information was unknown.Additional device information: concomitant medical products: the following devices were used in conjunction with the transmitter: cns-6801a: model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 10/06/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Org: model #: org-9110a.Serial #: (b)(6).Device manufacturer data: 11/10/2012.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
 
Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter was not recording any vitals or readings at the central nurse's station (cns) or on the device itself.There were no error messages displayed.Technical support (ts) had the bme replace the transmitter with a working one to continue patient monitoring activities.After further troubleshooting, ts was able to determine that the problem followed the transmitter.Bme confirmed there was no physical damage or fluid intrusion to the unit.No patient harm was reported.Investigation summary: nihon kohden (nk) received the complaint device on 08/11/2023.Nk repair center (rc) evaluated the device on 11/08/2023 and could not duplicate the complaint.Nk rc connected the unit to a cns and plugged it into a simulator.They also found that the insulator in the battery port was damaged and that there was fluid intrusion.Rc also found that the unit was repaired with the wrong center case.A definitive root cause could not be determined since we could not duplicate the complaint.The possible cause was most likely due to hardware component failure from physical damage and fluid intrusion to the internal components, which can occur through user mishandling.Damage to the insulator battery port can occur if excessive force is applied while inserting or removing batteries.Fluid intrusion may occur if the device is exposed to fluid and is not properly secured to the patient or the patient's bedside.The operator's manual lists general handling instructions for the zm transmitter.A review of the complaint device's serial number does not show other complaints.Review of the customer's complaint history did not show any trend for this issue and device.Nk will continue to monitor and trend similar complaints.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 07/25/2023 emailed the bme for the patient information and the concomitant medical devices: no reply was received.Attempt # 2: 07/27/2023 emailed the bme for the patient information and the concomitant medical devices: the bme responded with the concomitant medical devices, but the patient information was unknown.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: cns-6801a model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 10/06/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Org: model #: org-9110a.Serial #: (b)(6).Device manufacturer data: 11/10/2012.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Additional information: b4 date of this report.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.H10 additional manufacturer narrative.
 
Event Description
The biomedical engineer (bme) reported that the telemetry transmitter was not recording any vitals or readings at the central nurse's station (cns) or on the device itself.There were no error messages displayed.No patient harm was reported.
 
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Brand Name
ZM-531PA
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
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key17567450
MDR Text Key321375836
Report Number8030229-2023-03733
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921115107
UDI-Public04931921115107
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,Followup
Report Date 11/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberZM-531PA
Device Catalogue NumberZM-531PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2015
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; CNS; ORG; ORG
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