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

Model Number ZM-530PA

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the transmitter zm-530pa is being used with different spo2 probes and the customer reported that the unit is displaying low spo2 readings.They replaced with new probes and have tried troubleshooting steps but the issue persists.There are additional transmitters that are having this issue and are using the same probes.No patient harm has been reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The biomedical engineer reported that the transmitter zm-530pa is being used with different spo2 probes and the customer reported that the unit is displaying low spo2 readings.They replaced with new probes and have tried troubleshooting steps but the issue persists.There are additional transmitters that are having this issue and are using the same probes.No patient harm has been reported.

Manufacturer Narrative

Complaint details: the customer reported on (b)(6) 2019 that their device is showing multiple patients with low spo2 readings when patients have normal spo2 readings.Service requested: troubleshooting.Service provided: troubleshooting.Investigation result: the customer provided product information for the devices which were suspected to be associated with the issue: zm-530pa, sn:(b)(4) sw: 1-12 org-9100a, sn: (b)(4) sw: 03-05 pu-621ra: 01744 sw: 02-40 a review of service history of zm-530pa sn:(b)(4), org-9100a, sn: (b)(4), and pu-621ra: (b)(4) found no previously reported issue with spo2 readings.A review of complaints reported by (b)(6) found the following complaint: (b)(4), reported on (b)(6) 2019- spo2 failure.Not powering probe; root cause: maintenance needed the probes were investigated from the site.While one was not working at all, the other two tested accurately against a simulator on all simulator.The customer later said that the they switched to rubber probes and the issue was resolved.The root cause of the issue could not be confirmed as the issue with the probe could not be duplicated while tested on simulator.Corrected information: approximate age of device: incorrectly calculated.Date received by manufacturer: should be 03/21/2019 not 04/18/2019 as listed on mdr initial report.Additional information: if follow-up, what type? additional information correction.The following devices were involved in this complaint: org-9100a sn: (b)(4), pu-621ra.Sn: (b)(4).Spo2 probes that were used in conjunction with the device is: model: tl-201t.Lot: unknown.Expiration: unknown.Udi #: (b)(4).Date probes returned: april 22, 2019.

Event Description

The biomedical engineer reported that the transmitter zm-530pa is being used with different spo2 probes and the customer reported that the unit is displaying low spo2 readings.They replaced with new probes and have tried troubleshooting steps but the issue persists.There are additional transmitters that are having this issue and are using the same probes.No patient harm has been reported.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 8530142
• MDR Text Key: 142482849
• Report Number: 8030229-2019-00108
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2019
• Distributor Facility Aware Date: 11/05/2019
• Device Age: 90 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2019
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: TL-201T.