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

Model Number	ZM-530PA
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The biomedical engineer (bme) reported that the heart rhythms from this telemetry transmitter (tele) are showing artifacts.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the heart rhythms from this telemetry transmitter (tele) are showing artifacts.No patient harm was reported.
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bme) reported that the heart rhythms from this telemetry transmitter (tele) are showing artifacts.No patient harm was reported.Investigation conclusion: the evaluation of the returned device was not able to duplicate the reported issue.The device was tested on a simulator and no issues were observed.As the issue could not be duplicated, the root cause cannot be determined.The zm-530pa (sn: (b)(6)) with ch 9116 showed no signs of visible damage or scratches and showed signs of liquid intrusion.All leads (1, 2, 3, va, and vb), as well as hr and spo2, were tested using a simulator and monitored by cns-6201.The report was not duplicated, the issue appears to be on the customer's side.It is thought that the issue is related to the leads, network, ord, amp, or antenna.The following fields are not applicable (na) to the mdr report: b2 d4 lot number & expiration d6a - d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 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 (b)(6) 2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6) 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.Corrected information: **udi related data quality updates** d4 unique device identifier (udi) #: corrected the udi # to include the pi information.Additional information: b4 date of this report d9 device available for evaluation 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 h11 additional manufacturer narrative h11 corrected data.

• Brand Name: ZM-530PA
• Common Device Name: 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 Key: 18899291
• Report Number: 8030229-2024-04163
• Device Sequence Number: 7477367
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION; MULTIPLE PATIENT RECEIVER; MULTIPLE PATIENT RECEIVER
• Patient Sex: Unknown