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

Model Number ZM-530PA

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the patient name, information, and waveform disappeared from the screen of the transmitter device (zm-530pa).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, information, and waveform disappeared from the screen of the transmitter device (zm-530pa).No consequence or impact to the patient was reported.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019 customer submitted the log entry from the facility stating that "vanished from monitor name and info/waves".Customer stated they could not provide any information regarding the entry note.Due to the lack of information available.Investigation conclusion: an investigation into the reported issue is not possible at this time.No risk assessment could be performed.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: d4: serial number.F9: approximate age of device.No serial number was provided, so the age of the device is unknown.H4: device manufacturer date.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? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The customer reported that the patient name, information, and waveform disappeared from the screen of the transmitter device (zm-530pa).No consequence or impact to the patient was reported.

• 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: 9727553
• MDR Text Key: 199994621
• Report Number: 8030229-2019-00502
• 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: 02/19/2020

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-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2020
• Distributor Facility Aware Date: 02/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1