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

Model Number ZM-530PA

Device Problems Delayed Alarm (1011); Protective Measures Problem (3015)

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

Event Date 07/15/2023

Event Type  malfunction  

Manufacturer Narrative

The nurse director reported that there was a missed spo2 alarm on this telemetry transmitter.The nurse director said at the cns they saw the o2 actively dropping but it never alarmed until it hit 50.The nurse director said the spo2 dipped below threshold at 10:36-10:42 but did not start alarming until 10:49.The parameter was set to 89 and was not changed, even when they checked before and after this issue.No patient injury or death was reported.The nurse director sent the logs of the events for nihon kohden to review.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.

Event Description

The nurse director reported that there was a missed spo2 alarm on this telemetry transmitter.The nurse director said at the cns they saw the o2 actively dropping but it never alarmed until it hit 50.The nurse director said the spo2 dipped below threshold at 10:36-10:42 but did not start alarming until 10:49.The parameter was set to 89 and was not changed, even when they checked before and after this issue.No patient injury or death was reported.The nurse director sent the logs of the events for nihon kohden to review.

Event Description

The nurse director reported that there was a missed spo2 alarm on this telemetry transmitter.The nurse director said at the cns they saw the o2 actively dropping but it never alarmed until it hit 50.The nurse director said the spo2 dipped below threshold at 10:36-10:42 but did not start alarming unitl 10:49.The parameter was set to 89 and was not changed, even when they checked before and after this issue.No patient injury or death was reported.The nurse director sent the logs of the events for nihon kohden to review.

Manufacturer Narrative

Details of complaint: the nurse director reported that there was a missed spo2 alarm on this telemetry transmitter.The nurse director said at the cns they saw the o2 actively dropping but it never alarmed until it hit 50.The nurse director said the spo2 dipped below threshold at 10:36-10:42 but did not start alarming unitl 10:49.The parameter was set to 89 and was not changed, even when they checked before and after this issue.No patient injury or death was reported.The nurse director sent the logs of the events for nihon kohden to review.Investigation results: nihon kohden investigated the logs received from the customer for the times of reported events and found that there was the log indicating that the spo2 value became under 89% and the alarm was detected correctly at around 10:37am and 10:41am on (b)(6)2023 at the bed in question.There was the log indicating the alarm was silenced manually just after each alarm occurred as well.It was confirmed that the alarm went off normally and the alarm was silenced by the user's operation.It was confirmed that the product had been working normally as specified.When silencing the alarm, please silence after checking the generated alarm.Review of the cns logs showed that the unit alarmed as expected and there was no confirmed malfunction of the cns.Review of the complaint device's serial number does not show recurrence.Nk will continue to monitor and trend similar complaints.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 07/19/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 07/31/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 08/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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: 17495486
• MDR Text Key: 321053123
• Report Number: 8030229-2023-03698
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• 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-9100A; ORG-9100A