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

Model Number	ZM-520PA
Medical Device Problem Codes	Device Alarm System (1012); Protective Measures Problem (3015)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that their transmitter missed an arrhythmia alarm.No patient harm or injury 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.
Event or Problem Description
The customer reported that their transmitter missed an arrhythmia alarm.No patient harm or injury was reported.
Event or Problem Description
The customer reported that their transmitter missed an arrhythmia alarm.No patient harm or injury was reported.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2020, the customer reported that the transmitter missed an arrhythmia alarm.No patient harm or injury was reported.Nihon kohden (nk) technical support (ts) contacted the customer and found that the reported problem has been resolved.However, the customer provided no information as to how.Service requested / performed: troubleshooting.Investigation summary: no root cause could be established as the customer provided no additional information regarding this event.The overall risk of this event is "low." the reported issue does not require further investigation through capa process.The following fields are not applicable (na) to the mdr report: d4 lot # & expiration date g4 device bla number the following fields contain no information (ni), as attempts to obtain information were made, but not provided: additional device information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: cns: model #: ni serial #: ni additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• Brand Name: ZM-520PA
• 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: 10171763
• Report Number: 8030229-2020-00324
• Device Sequence Number: 13991511
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021
• Report Date (Section F): 06/18/2020

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-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/27/2020
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS
• Date Report Sent to FDA: 06/18/2020