MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the patient name disappeared from the screen of the transmitter device (zm-530pa) and that unit showed a "patient not found" error message.No consequence or impact to the patient was reported.The customer indicated that they will not be providing any additional information regarding the event.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 Description

The customer reported that the patient name disappeared from the screen of the transmitter device (zm-530pa) and the unit showed a "patient not found" error message.No consequence or impact to the patient was reported.

Event Description

The customer reported that the patient name disappeared from the screen of the transmitter device (zm-530pa) and the unit showed a "patient not found" error message.No consequence or impact to the patient was reported.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at mercy health partners reported the following issue: monitor reading patient not found.Mrv still approve but no patient name.Patient had been here for over 20 days in the icu.This was provided to nka technical support (ts) from the hospital's department logs.The incident occurred on (b)(6) 2019 for transmitter (zm-530pa sn: ni).No further information will be provided from the hospital.Service requested: none.Service performed: none.Investigation result: there was a reported incident in which the monitor was reported to display error message "patient not found" for a transmitter (zm-530pa).The details surrounding the incident were not provided and information on the extent of any troubleshooting is unknown.Review of tickets opened at mercy health partners found one issue reported relating to message "patient not found": 67539 reported (b)(6) 2019.The g9 unit was reported to display message on the cns and the patient had been in the hospital for 26 days.This is currently under investigation in irc-nka300181219.The incident description appears similar to the issue described for the transmitter however no conclusion can be made with the available information.Investigation conclusion: further investigation of the issue is limited as device logs were not retrieved for evaluation, nor was the device serial number provided.Based on the information provided, it is not possible to make any determination of the root cause.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: serial number.Approximate age of device.No serial number was provided, so the age of the device is unknown.Device manufacturer date.Additional information: date of this report.Date user facility/importer became aware of the event.Type of report.Date report sent to fda.Date report sent to manufacturer.Date received by manufacturer.Type of report.If follow-up, what type? device evaluated by manufacturer.Event problem and evaluation codes.Additional manufacturer narrative.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 9126435
• MDR Text Key: 198927825
• Report Number: 8030229-2019-00487
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2019
• Distributor Facility Aware Date: 12/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.