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

Model Number ZM-920PA

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

Event Type  malfunction  

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 Description

The customer reported that the transmitter heart rate fluctuating and not showing a constant number.No consequence or impact to the patient.

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 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
• Type of Device: 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
• MDR Text Key: 149942904
• Report Number: 8030229-2019-00264
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921000694
• UDI-Public: 04931921000694
• Combination Product (y/n): N
• PMA/PMN Number: K945578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 09/06/2019
• Distributor Facility Aware Date: 09/05/2019
• Device Age: 179 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1