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

Model Number ZM-531PA

Device Problems Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 05/15/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was not holding power.After 10 minutes, the device will shut off automatically.You will need to remove the battery and put it back in for it to come back up.They tried different batteries and even tested the batteries to make sure enough voltage is going through.The staff did not know if an error message was displayed on the central nurse's station (cns) to alert the user of the issue.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter was not holding power.After 10 minutes, the device will shut off automatically.You will need to remove the battery and put it back in for it to come back up.They tried different batteries and even tested the batteries to make sure enough voltage is going through.The staff did not know if an error message was displayed on the central nurse's station (cns) to alert the user of the issue.No patient harm was reported.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 are not applicable (na) to the mdr report: d4 lot number & expiration; d6a - d6b; d7b; f1 - f14; g4 device bla number; the following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6 b6 - b7 d10 concomitant medical device.Attempt #1 05/17/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details.Attempt #2 05/26/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 05/30/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and additional device information as requested.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the telemetry transmitter was not holding power.After 10 minutes, the device will shut off automatically.You will need to remove the battery and put it back in for it to come back up.They tried different batteries and even tested the batteries to make sure enough voltage is going through.The staff did not know if an error message was displayed on the central nurse's station (cns) to alert the user of the issue.No patient harm was reported.Service performed and investigation conclusion: nihon kohden (nk) received the device on 06/21/2023.Nk repair center (rc) evaluated the device on 06/26/2023 and could not duplicate the complaint.Nk rc observed that over 24 hours passed before the device ran out of power and that it had intermittent signal loss.A definitive root cause could not be determined since the complaint could not be duplicated.Possible causes are likely related to the batteries used by the customer and wear-and-tear.Power requirements and voltage limits for the transmitter are listed in its operator's manual.It is possible that the customer was using batteries with voltage outside of the operating voltage range for the device.The operating range may also be affected by wear-and-tear of hardware components, which depends on the age of the device and frequency of use.Review of the device's serial number shows that it is over 5 years old and has no other complaints.Due to the device's age, wear-and-tear may be a likely contributing factor to the issue.Review of the customer's complaint history for the zm transmitter also did not show any other complaints.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.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was not holding power.After 10 minutes, the device will shut off automatically.You will need to remove the battery and put it back in for it to come back up.They tried different batteries and even tested the batteries to make sure enough voltage is going through.The staff did not know if an error message was displayed on the central nurse's station (cns) to alert the user of the issue.No patient harm was reported.

• Brand Name: ZM-531PA
• 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: 17122567
• MDR Text Key: 317758729
• Report Number: 8030229-2023-03593
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• 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: 09/08/2023

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-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• 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