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

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.

• 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: 18899291
• MDR Text Key: 337803971
• Report Number: 8030229-2024-04163
• 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: 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

• Date FDA Received: 03/13/2024
• 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: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTRAL NURSE'S STATION; MULTIPLE PATIENT RECEIVER