MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; CENTRAL MONITOR SYSTEM

Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported zm transmitter signal loss on individual tiles at the central nurse's station (cns).The report was created to document the department logs from the hospital.The hospital would not provide any additional information.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: brand name, model number, catalog number, serial number, unique identifier (udi) number.Approximate age of device.No serial number was provided, so the age of the device is unknown.Pma/510(k), device manufacturer date.Concomitant medical device: the following devices were used in conjunction with the cns.Zm transmitters: model #: zm-531, sn #: ni.Approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.) device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The customer reported zm transmitter signal loss on individual tiles at the central nurse's station (cns).The report was created to document the department logs from the hospital.The hospital would not provide any additional information.

Event Description

The customer reported zm transmitter signal loss on individual tiles at the central nurse's station (cns).The report was created to document the department logs from the hospital.The hospital would not provide any additional information.

Manufacturer Narrative

Details of the complaint: on 10/22/2019 customer submitted the log entry from the facility stating that "lots of multiple 'signal loss' on individual tiles on separate transmitters on several separate rooms, zm -531s." customer stated they could not provide any information regarding the entry note.Due to the lack of information available.An investigation into the reported issue is not possible currently.No risk assessment could be performed.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: d1 brand name.D4 model number.Catalog number.Serial number.Unique identifier (udi) number.F9 approximate age of device.No serial number was provided, so the age of the device is unknown.G5 pma/510(k).H4 device manufacturer date.Additional device information: d11 & c2 concomitant medical device: the following devices were used in conjunction with the cns.Zm transmitters.Model #: zm-531.Sn #: ni.Approximate age of the device: ni (no serial number was provided, so the age of the device is unknown).Device manufacturer date: ni.Unique identifier (udi) #: ni.

• Brand Name: NI
• Type of Device: CENTRAL MONITOR SYSTEM
• 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: 9501049
• MDR Text Key: 194789610
• Report Number: 8030229-2019-00734
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2020
• Distributor Facility Aware Date: 02/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TELEMETRY DEVICES.; TELEMETRY DEVICES.