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

Model Number	ZM-530PA
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported being unable to review data on this central nurse's station (cns) for their tele.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported being unable to review data on this central nurse's station (cns) for their tele.Technical support (ts) had the customer look at the stored and displayed wave setting and found out that no matter what, lead ii was not showing at all.The customer was only able to display trace 1 and lead i, which was not being used as the analysis lead.The customer will send in the transmitter unit to be exchanged.There was no patient injury 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 attempt # 1: 12/29/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for cathy to call me back with this information as well an email address.Attempt # 2: 01/10/2024 a phone call was made in an attempt to gather patient and device information; a voice mail was left for cathy to call me back with this information as well an email address.Attempt # 3 01/15/2024 a phone call was made in an attempt to gather patient and device information; a voice mail was left for cathy to call me back with this information as well an email address.B6 attempt # 1: 12/29/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for cathy to call me back with this information as well an email address.Attempt # 2: 01/10/2024 a phone call was made in an attempt to gather patient and device information; a voice mail was left for cathy to call me back with this information as well an email address.Attempt # 3 01/15/2024 a phone call was made in an attempt to gather patient and device information; a voice mail was left for cathy to call me back with this information as well an email address.B7 attempt # 1: 12/29/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for cathy to call me back with this information as well an email address.Attempt # 2: 01/10/2024 a phone call was made in an attempt to gather patient and device information; a voice mail was left for cathy to call me back with this information as well an email address.Attempt # 3 01/15/2024 a phone call was made in an attempt to gather patient and device information; a voice mail was left for cathy to call me back with this information as well an email address.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the zm transmitter: cns: model #: pu-681ra.Serial #: 1309.Device manufacturer date: 03/03/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: no.
Event or Problem Description
The customer reported being unable to review data on this central nurse's station (cns) for their tele.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported being unable to review data on this central nurse's station (cns) for their tele.Technical support (ts) had the customer look at the stored and displayed wave setting and found out that no matter what, lead ii was not showing at all.The customer was only able to display trace 1 and lead i, which was not being used as the analysis lead.The customer will send in the transmitter unit to be exchanged.There was no patient injury reported.Investigation summary: evaluation from repair center showed that the transmitter had no signs of damage or scratches.All leads (1, 2, 3,va and vb) were tested using a simulator and monitored by the (b)(6).The reported issue could not be duplicated and confirmed.A definitive root cause could not be determined.The issue appears to be on the customer's side, likely related to the network, such as org, amp, or the antenna.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the zm transmitter: cns: model #: pu-681ra, serial #: (b)(6), device manufacturer date: 03/03/2020, unique identifier (udi) #: (b)(4), returned to nihon kohden: no.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h11 additional manufacturer narrative.Udi related data quality updates corrected information: d4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.

• 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: 18527782
• Report Number: 8030229-2024-04021
• Device Sequence Number: 6383134
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2020
• 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: CNS.; CNS.
• Patient Sex: Unknown