MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120PA; TRANSMITTER

Model Number	GZ-120PA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the ecg readings are all over the board on the transmitter.As soon as you turn the unit on rhythm goes to 120 then 150 down to 80 back up and it is set to read 80 on the simulator.The unit was in use and was the biomed was able to duplicate the issue.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 if additional information becomes available.Concomitant medical device information was requested from the customer, but the customer does not know the model or the serial number of the central nurse's system that was used with this transmitter.Therefore this field contains no information (ni).Cns model and serial number unknown.
Event or Problem Description
The biomedical engineer reported that the ecg readings are all over the board on the transmitter.As soon as you turn the unit on rhythm goes to 120 then 150 down to 80 back up and it is set to read 80 on the simulator.The unit was in use and was the biomed was able to duplicate the issue.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the ecg readings were all over the board, and when testing the transmitter on a simulator, the heart rhythm reading jumped around from 120 to 150 to 80.The simulator was set at 80.The device was sent to nka for evaluation / exchange.No patient harm was reported.Service requested / performed: exchange / evaluation: the reported issue was duplicated.A rattling noise and damaged ecg connector was noted.Investigation summary: the root cause is attributable to device damage.The service history for this device shows this is an isolated incident.Further action is not warranted at this time.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.D10 concomitant medical device.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 ecg readings were all over the board, and when testing the transmitter on a simulator, the heart rhythm reading jumped around from 120 to 150 to 80.The simulator was set at 80.

• Brand Name: GZ-120PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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: 8891036
• Report Number: 8030229-2019-00365
• Device Sequence Number: 262495
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K153707
• 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): 03/01/2022
• Report Date (Section F): 08/13/2019

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: GZ-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/19/2019
• Device Age: 30 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2017
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/13/2019