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

Model Number ZM-531PA

Device Problem Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter is getting low spo2 reading from the new nk spo2 cables.They stated that they have a batch of these spo2 probes that are giving them low spo2 readings.The reading are around 90 or 92 %.They have tried a few of these cables on different equipment and on simulators, and they get low readings on all of them.This is happening with a new batch of nk spo2 probes that they just got in.The customer has gone back to the old spo2 cables that they where using before they got these and they are having no issues with these cables.They are returning the probes.No patient harm 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.Additional device information: concomitant medical device: the following devices were being used in conjunction with the telemetry transmitter.Spo2 sensor: model: nk-spo2-advt, sn: (b)(4).

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter is getting low spo2 reading from the new nk spo2 cables.They stated that they have a batch of these spo2 probes that are giving them low spo2 readings.The reading are around 90 or 92 %.They have tried a few of these cables on different equipment and on simulators, and they get low readings on all of them.This is happening with a new batch of nk spo2 probes that they just got in.The customer has gone back to the old spo2 cables that they where using before they got these and they are having no issues with these cables.They are returning the probes.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter was giving low spo2 readings from a new batch of nk spo2 cables.The readings were around 90 or 92%.Testing these cables on different equipment and on simulators, showed that the issue followed the cables.No patient harm or injury was reported.Investigation summary: a probable cause was that the customer's equipment was out of calibration or faulty equipment was set up.The investigation found that pulse oximetry measurement of spo2 is dependent on the following factors: probe placement; adequate circulation at placement site; functioning probe; appropriate parameter setup; inter-device communication; pause/resume functionality of the patient connected device.The cns operator's manual listed the following error messages that would be displayed should the device detect spo2 issues: zm operator's manual states the following: the manufacturer's analysis shows that in the majority of the probes tested (18 out of 20), the reported issue could not be duplicated.No issues were observed.The cause for the two probes being out of tolerance is unknown.Taken together, the analysis shows that reported issue was likely due to the way these probes were tested.There is no indication of probe failure.Service history for this this facility shows 8 tickets created between 07/30/2020 and 08/31/2020 for the same issue.There has been no subsequent recurrence of the reported issue.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was giving low spo2 readings from a new batch of nk spo2 cables.The readings were around 90 or 92%.Testing these cables on different equipment and on simulators, showed that the issue followed the cables.No patient harm 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10469268
• MDR Text Key: 204926025
• Report Number: 8030229-2020-00489
• 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: 08/28/2020,03/09/2023

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-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2020
• Distributor Facility Aware Date: 07/30/2020
• Device Age: 56 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2020
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• 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: NK-SPO2-ADVT SN (B)(6); NK-SPO2-ADVT SN (B)(6)