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.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.Attempt #1: 07/14/2021: emailed customer via (b)(6) for all items under the no information section.No reply was received.Attempt #2: 07/21/2021: emailed customer via (b)(6) for all items under the no information section.No reply was received.Attempt #3: 07/27/2021: emailed customer via (b)(6) for all items under the no information section.No reply was received.
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.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the transmitter gave them a false reading of asystole after which their staff panicked and gave the patient medication to prevent a heart attack, which was not needed because the patient was not actually in asystole.There was no patient harm as a result of this incident.Investigation summary: as no devices were returned for evaluation relating to this event nor were any device logs provided for analysis, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Good faith efforts have been sent to the customer to obtain additional information, but the attempts have not resulted in additional information.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.The cause of false alarming may be due to inaccurate data being recorded.Inaccurate data may be a result of device failure, hardware failure, poor patient prep, faulty leads, or poor lead placement.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt #1 (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.
Event or Problem Description
The customer reported that the transmitter gave them a false reading of asystole after which their staff panicked and gave the patient medication to prevent a heart attack, which was not needed because the patient was not actually in asystole.There was no patient harm as a result of this incident.

• 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
• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12236607
• Report Number: 8030229-2021-01431
• Device Sequence Number: 19753322
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown