MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

Device Problems Failure to Select Signal (1582); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the transmitter was not sending ecg(electrocardiogram) waveforms to the bedside or cns (central nursing station).When a known working transmitter was connected to the receiver and it connected and the ecg(electrocardiogram) waveforms were displayed.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.Attempt #1: emailed customer via microsoft outlook for patient information, relevant tests/labs, other relevant history and concomitant devices being monitored: no reply was received.Attempt #2: emailed customer via microsoft outlook for patient information, relevant tests/labs, other relevant history, and concomitant devices being monitored: no reply was received.Attempt #3: emailed customer via microsoft outlook for patient information, relevant tests/labs, other relevant history, and concomitant devices being monitored: no reply was received.

Event Description

The biomedical engineer (bme) reported that the transmitter was not sending ecg(electrocardiogram) waveforms to the bedside or cns (central nursing station).

Event Description

The biomedical engineer (bme) reported that the transmitter was not sending ecg (electrocardiogram) waveforms to the bedside or cns (central nursing station).

Manufacturer Narrative

Details of complaint: on 02/09/2021, the customer at kaiser permanente reported the following issue with zm-531pa; sn-(b)(6), from patient monitoring: the transmitter was not sending ecg waveforms to the bedside or cns.When a known working transmitter was connected to the receiver, it connected, and the ecg waveforms were displayed.No patient harm was reported.They would like to send the unit in for repair.Service requested: repair / evaluation.Service performed: on 04/20/2021, the unit was cleaned and decontaminated by nka rc.Physical damage was noticed.On rc evaluation, the reported problem could not be duplicated.Numeric values and waveforms of the monitoring parameters were displayed correctly on the lcd screen and on the cns.Extensive tests were performed but no problem could be found.The unit was tested per the zm-530/531pa operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 24 hours of extended testing and operated to the manufacturer's specifications.Investigation summary: nka rc could not duplicate the issue.Per the operator's manual, the possible cause of the ecg waveforms not being displayed is "ecg measurement" on the "parameter setup" screen is set to off.The overall risk of this event, taking into consideration of severity and probability, is "medium." the reported issue does not require further investigation through capa process since nka rc evaluation suggested no nk device deficiency and the patterning did not suggest any persistence of similar issues in the past.The following fields are not applicable (na) to this report: b2, d4 lot # & expiration date, d6a & d6b, d7b, f1 - f14, g4 device bla number, g7, h7, h9.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6, b6, b7.Attempt #1: 02/19/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs, other relevant history and concomitant devices being monitored: no reply was received.Attempt #2: 03/05/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs, other relevant history, and concomitant devices being monitored: no reply was received.Attempt #3: 03/07/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs, other relevant history, and concomitant devices being monitored: no reply was received.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the transmitter: bsm: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Additional information: b4 date of this report.D9 device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• 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: 11464118
• MDR Text Key: 244856587
• Report Number: 8030229-2021-00135
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BSM; CNS