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

Model Number ZM-530PA

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the transmitter was displaying greater then normal artifact.The bme also reported that the patient monitoring was interupted for about 15 minutes as the transmitter lost communication with the central nurse's station (cns).No patient harm or injury was reported.The customer tested the unit on a simulator and with different leads, and is reporting that the problem still persists.Nihon kohden received the unit for further evaluation.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 cns was used in conjunction with the transmitter as the primary monitor, but did not experience a failure.Attempts to obtain the following information were made, but not provided: cns - model: ni s/n: ni approximate age of the device: no serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The biomedical engineer (bme) reported that the transmitter was displaying greater then normal artifact.The bme also reported that the patient monitoring was interupted for about 15 minutes as the transmitter lost communication with the central nurse's station (cns).

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6).Reported receiving a large amount of artifact for the ecg readings on the transmitter (zm-530pa sn: (b)(6)).The unit was tested on a simulator, with different leads and the problem still persisted.Patient monitoring was interrupted for about fifteen minutes.Investigation summary: as the reported issue could not be duplicated with the nka test environment, the probable root cause may be environment or condition at the facility which cause electromagnetic interference.From the information currently available, the root cause could not be confirmed.The device was evaluated and found to be operating per specifications.The overall risk, as determined from the product of probability (rare) and severity(insignificant), is determined to be low.D11 & c2: the cns was used in conjunction with the transmitter as the primary monitor, but did not experience a failure.Attempts to obtain the following information were made, but not provided: cns - model: ni.S/n: ni.Approximate age of the device: no serial number was provided, so the age of the device is unknown.Device manufacturer date: ni.Unique identifier (udi) #: ni.

Event Description

The biomedical engineer (bme) reported that the transmitter was displaying greater then normal artifact.The bme also reported that the patient monitoring was interrupted for about 15 minutes as the transmitter lost communication with the central nurse's station (cns).

• 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: 8947886
• MDR Text Key: 198917800
• Report Number: 8030229-2019-00421
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2020
• Distributor Facility Aware Date: 03/24/2020
• Device Age: 43 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS; CNS