MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number	ZM-541PA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the transmitter is giving low blood pressure readings and is off by 20 points, and also is giving an nibp error.No patient harm reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.The following devices were being used in conjunction with the transmitter.Central nurses station (cns) however the user did not know the model and serial number of the cns that was being used with this particular transmitter.
Event or Problem Description
The customer reported that the transmitter is giving low blood pressure readings and is off by 20 points, and also is giving an nibp error.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the transmitter was giving low blood pressure readings and was off by 20 points.Additionally, the device was giving an nibp error.No patient harm was reported.Service requested / performed: troubleshooting: an exchange unit was shipped to the customer on (b)(6) 2019 to resolve the issue.On 01/07/2022, the reported device was cleaned and decontaminated by nihon kohden repair center (nk rc).No physical damage was noticed.Upon rc evaluation, the reported problem could not be duplicated.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.Per the zm-541pa operator's manual, possible causes of displayed abnormal nibp measurements are: · incorrect cuff size.· incorrect cuff placement.· movement of the patient or the cuff during measurements.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 readings between the transmitter and the monitor to be acceptable.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 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.D9 device available for evaluation? 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.Corrected information: b6 relevant tests/laboratory data: replaced the description of the event with "na" as that information is not relevant to this field.
Event or Problem Description
The customer reported that the transmitter is giving low blood pressure readings and is off by 20 points, and also is giving an nibp error.No patient harm reported.

• 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 CORPORATION; attn: shama mooman; 1-1 tajino; tokyo, 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: 8741169
• Report Number: 8030229-2019-00249
• Device Sequence Number: 14027471
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/01/2022
• Report Date (Section F): 06/27/2019

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-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/06/2019
• Device Age: 65 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2014
• 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; CNS
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/27/2019