MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number ZM-521PA

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter's electrocardiogram (ecg) data was dropping off the central nurse's station (cns).Not in patient use.

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter's electrocardiogram (ecg) data was dropping off the central nurse's station (cns).They tried swapping cables, leads, and batteries, but the issue persisted.Not in patient use.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 field contains no information (ni), as attempts to obtain information were made, but not provided: d10.Attempt # 1: 06/21/2023 emailed the bme concomitant medical device: no reply was received.Attempt # 2: 06/27/2023 emailed the bme concomitant medical device: the bme responded, "the unit was sent back." no other information was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Org: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter's electrocardiogram (ecg) data was dropping off the central nurse's station (cns).They tried swapping cables, leads, and batteries, but the issue persisted.Not in patient use.Investigation summary: nihon kohden (nk) received the device on 07/07/2023.Nk repair center (rc) evaluated the unit on 09/15/2023 and could not duplicate the complaint.Nk rc connected the unit to a cns and saw that the ecg waveforms were visible.The unit was then tested away from the cns, and it showed intermittent signal loss.Nk rc also found that the main panel on the unit did not match the unit.A definitive root cause could not be determined since we could not duplicate the complaint.Based on the issues observed during evaluation, possible causes may include hardware component failure, which can occur through physical damage or fluid intrusion from user mishandling, power issues from incorrect battery use/insertion which can lead to short-circuiting, or wear-and-tear, which depends on device age and frequency of use.A review of the complaint device's serial number shows that the unit is 5 years old and has no other complaints.Due to the age of the device, wear-and-tear may be a likely contributing factor to possible hardware failure.A review of the customer's complaint history did not reveal any trends.Nk will continue to monitor and trend similar complaints.The following field contains no information (ni), as attempts to obtain information were made, but not provided: d10 attempt # 1: 06/21/2023 emailed the bme concomitant medical device: no reply was received.Attempt # 2: 06/27/2023 emailed the bme concomitant medical device: the bme responded, "the unit was sent back." no other information was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na org: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na additional information: b4 date of this report 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.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter's electrocardiogram (ecg) data was dropping off the central nurse's station (cns).Not in patient use.

• Brand Name: ZM-521PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17339493
• MDR Text Key: 319438126
• Report Number: 8030229-2023-03651
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

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-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CNS; CNS; ORG; ORG