MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

Device Problems Erratic or Intermittent Display (1182); Output Problem (3005)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the transmitter was experiencing sporadic ecg waveform output.The unit would also read the heart rate (hr) low, then spike high and alarm asystole.The bme tested the transmitter on a simulator and received the same results.There was no physical damage or fluid intrusion.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 field contains no information (ni), as attempts to obtain the information were made, but not provided: additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: cns: model #: ni, serial (b)(6), device manufacturer data: ni, unique identifier (b)(4), returned to nihon kohden: na.Org: model #: org-9110a, serial (b)(6), device manufacturer data: 25/02/2021, unique identifier (b)(4), returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the transmitter was experiencing sporadic ecg waveform output.The unit would also read the heart rate (hr) low, then spike high and alarm asystole.No patient harm was reported.

• 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 Key: 18622711
• MDR Text Key: 334850789
• Report Number: 8030229-2024-04106
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2023
• 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; ORG
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White