MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-920PA

Model Number	ZM-920PA
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the transmitter heart rate fluctuating and not showing a constant number.No consequence or impact to the patient.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the transmitter heart rate fluctuating and not showing a constant number.No consequence or impact to the patient.
Additional Manufacturer Narrative
Details of the complaint: on (b)(6) 2019, customer at (b)(6) hospital reported the transmitter (zm-920pa sn: (b)(6) hr was fluctuating and not showing a constant number.Service requested: troubleshooting/assistance.Service performed: customer moved the transmitter out of service and no further action needed.Investigation result(s): the device warranty began 12/05/2004, which is over 14 years prior to the reported issue.Review of device sap history found no previously reported issues with the unit.Review of tickets opened at the facility found: (b)(4) reported on (b)(6) 2019 reported for zm-920pa sn: (b)(6) regarding hr reading problems.The zm-920pa model was formally discontinued on 01/01/2012 in mbg-140013 due to the introduction of zm-52xpa/zm53xpm telemetry transmitters.Support for the unit continued for a minimum period of seven years.The issue occurred well beyond the warranty and promised support period.Customer removed the unit from service to resolve the issue.No nka evaluation was performed.Review of similar tickets using keywords "zm-920pa hr" found no additional related issues.Per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.The root cause could not be determined from the information available.No adverse trend for this issue found.This issue is not suspected to be caused by deficient design.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.
Event or Problem Description
The customer reported that the transmitter heart rate fluctuating and not showing a constant number.No consequence or impact to the patient.

• Brand Name: ZM-920PA
• Common Device Name: ZM-920PA
• 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: 8755869
• Report Number: 8030229-2019-00264
• Device Sequence Number: 11272130
• Product Code: DRG
• UDI-Device Identifier: 04931921000694
• UDI-Public: 04931921000694
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K945578
• 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): 09/06/2019
• Report Date (Section F): 09/06/2019

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-920PA
• Device Catalogue Number: ZM-920PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/05/2019
• Device Age: 179 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/06/2019