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

Model Number ZM-530PA

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  malfunction  

Event 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.

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.

• 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 Key: 18527782
• MDR Text Key: 333255398
• Report Number: 8030229-2024-04021
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CNS.