MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number	ZM-541PA
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that their transmitter gave them a false reading of asystole after which their staff panicked and gave their patient medication to prevent an insinuated heart attack.They also said that the patient is fine but the staff had to go through these steps unnecessarily due to the false readings.
Event or Problem Description
The customer reported that their transmitter gave them a false reading of asystole after which their staff panicked and gave their patient medication to prevent an insinuated heart attack.They also said that the patient is fine but the staff had to go through these steps unnecessarily due to the false readings.

• Brand Name: ZM-541PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 12236653
• Report Number: 2080783-2021-01431
• Device Sequence Number: 19750571
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/27/2021
• Report Date (Section F): 07/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: ZM-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/28/2021
• Device Age: 116 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 07/27/2021