MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number ZM-520PA

Device Problems Computer Software Problem (1112); Data Problem (3196); Patient Data Problem (3197)

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

The biomed reported that the previous day a patient had coded and they noticed data was not recorded.The data had about a 10-11min gap where it was blank.Waveforms were still displaying on the screen but not recorded.No known impact or consequence to the patient.Nihon kohden continues to investigate the reported event.The following fields are not applicable (na) to this report: b2 d4 lot # & expiration date d6a & d6b d7b d10 g1 - g8 h1- h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6, b6, b7 attempt #1: 01/22/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs and other relevant history: no reply was received.Attempt #2: 02/01/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs, and other relevant history: no reply was received.Attempt #3: 02/08/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs, and other relevant history: no reply was received.

Event Description

The biomed reported that the previous day a patient had coded and they noticed data was not recorded.The data had about a 10-11min gap where it was blank.Waveforms were still displaying on the screen but not recorded.No known impact or consequence to the patient.

• Brand Name: ZM-520PA
• 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
• MDR Report Key: 11335638
• MDR Text Key: 232608338
• Report Number: 2080783-2021-00083
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 4931921115077
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2021

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
• Device Operator: Health Professional
• Device Model Number: ZM-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2021
• Distributor Facility Aware Date: 01/22/2021
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1