MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number	ZM-521PA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that their transmitter is showing incorrect hr readings.The customer also reported that this transmitter is showing different reading than their central nurse's station (cns).No harm or injury was reported.They will be sending this unit in for an exchange.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Concomitant medical products: the following device was used in conjunction with the transmitter: centra nurse's station (cns), model: ni, sn: ni.
Event or Problem Description
The customer reported that their transmitter is showing incorrect hr readings.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the transmitter was showing incorrect heart rate (hr) readings.They also reported that this transmitter was showing different readings than the central nurse's station (cns).Additionally, they reported that the device had physical damage to the case and that a button was missing.They will be sending this unit in for an exchange.No harm or injury was reported.Service performed: exchange.Investigation summary: the customer reported that the transmitter had physical damage to the case and buttons.As the device was not evaluated, root cause cannot be determined.It is likely that the reported physical damage contributed to the heart rate not readings correctly as physical damage could also extend to the internal components of the transmitter.Based on the complaint history review of the customer account, there are 3 additional complaints relating to physical damage to zm-520 transmitters.This event is likely an isolated incident based on the complaint history of the customer and occurrence of inaccurate values due to physical damage to zm-520 transmitters.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.
Event or Problem Description
The customer reported that the transmitter was showing incorrect heart rate (hr) readings.They also reported that this transmitter was showing different readings than the central nurse's station (cns).Additionally, they reported that the device had physical damage to the case and that a button was missing.

• Brand Name: ZM-521PA
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11068364
• Report Number: 8030229-2020-00777
• Device Sequence Number: 13779957
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/17/2022

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-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL NURSE'S STATION (CNS); CENTRAL NURSE'S STATION (CNS)
• Patient Sex: Unknown