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

Model Number	ZM-520PA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that one of their transmitter was not displaying any heart rate readings.The customer also reported that this transmitter was not sending the heart rate reading to the central nurse's station (cns).No patient harm or injury was reported.The transmitter was switched out with a working one, which resolved the issue.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.Additional model information: the cns was used in conjunction with the transmitter, but was not the device that experienced failure.Attempts to obtain the following information were made, but not provided: cns - model: ni.S/n: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni.Unique identifier (udi) #: ni.
Event or Problem Description
The customer reported that one of their transmitter was not displaying any heart rate readings.The customer also reported that this transmitter was not sending the heart rate reading to the central nurse's station (cns).
Event or Problem Description
The customer reported that one of their transmitters was not displaying any heart rate readings.The customer also reported that this transmitter was not sending the heart rate reading to the central nurse's station (cns).
Additional Manufacturer Narrative
Details of the complaint.On (b)(6) 2019, customer at (b)(6) health ctr reported heart rate was not shown on the cns or transmitter (zm-520pa sn: (b)(6)).Investigation summary: the approximate age of the unit was 7 years at the time of reported issue and the unit was beyond warranty.The unit has no prior nka complaint or servicing history which may be related to the current issue.As the unit was not returned, nka evaluation could not be performed and the root cause could not be determined.The overall risk is low.Additional model information: d11 & c2: the cns was used in conjunction with the transmitter, but was not the device that experienced failure.Attempts to obtain the following information were made, but not provided: cns - model: ni.S/n: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni.Unique identifier (udi) #: ni.

• Brand Name: ZM-520PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 9373390
• Report Number: 8030229-2019-00687
• Device Sequence Number: 19593885
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (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): 02/12/2020
• Report Date (Section F): 02/12/2020

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: 02/11/2020
• Device Age: 89 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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.; CNS.
• Date Report Sent to FDA: 02/12/2020