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 Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was provided with an exchanged device to resolve the issue.Nihon kohden's qa and technical services departments made unanswered attempts to obtain additional information on the event.It was not clear whether the malfunction occurred during patient setup or while monitoring the patient.There was no patient harm 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 biomedical engineer (bme) reported that the transmitter sent no wave or numerics to the central nurse's station (cns) and did not display them locally.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the transmitter sent no waveforms or numerics to the central nurse's station (cns) and did not display them locally.Nihon kohden's qa and technical services departments made unanswered attempts to obtain additional information regarding the event.It was not clear whether the malfunction occurred during patient setup or while monitoring the patient.There was no patient harm reported.Service requested / performed: evaluation / repair: an exchange unit was shipped to the customer on 07/17/2019.On 01/07/2022, the unit was cleaned and decontaminated by nihon kohden america repair center (nka rc).On rc evaluation, the reported problem could not be duplicated.No physical damage was noticed.Numeric values and waveforms of the monitoring parameters were displayed correctly on transmitter and at the cns.Investigation summary: the root cause of the issue could not be determined as the nk rc was not able to duplicate the issue upon evaluation.The possible causes of the ecg waveforms not showing on the receiving monitor, as per the zm transmitters operator's manual, is inconsistency of the channel, software version, or inconsistent protocols between the transmitter and the receiving monitor.Per hazard analysis document 0704-902878m, hazard #d074, if the measurement values are not consistent in the receiver (cns) and transmitter, possibly caused due to data being processed by each feature of the transmitter and cns, this can cause data inconsistency.The reported issue does not require further investigation through capa process since the issue could not be duplicated on rc evaluation.The device was performing as intended.Also, the cns manufacturer's hazard analysis determined the residual risk of inconsistent reading between the transmitter and the monitor is acceptable.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(s) were used in conjunction with the transmitter: cns: model#: ni.Serial#: ni.Org: 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? h3: device evaluated by manufacturer? h6: event problem and evaluation codes.H10: additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that the transmitter sent no wave or numerics to the central nurse's station (cns) and did not display them locally.

• 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
• 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: 8895549
• Report Number: 8030229-2019-00375
• Device Sequence Number: 318163
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022
• Report Date (Section F): 08/14/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2019
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2018
• 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: CNS.; NA.; ORG.
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/14/2019