MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-540PA; TRANSMITTER

Model Number	ZM-540PA
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this event has not been returned to date to allow for an analysis to be performed.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if the product is returned for evaluation or new information is obtained.
Event or Problem Description
The customer reported that the transmitter has an spo2 failure.No additional information regarding the event is available.No known impact or consequence to the patient.
Additional Manufacturer Narrative
(b)(6) reported on (b)(6) 2018 that their zm-540pa (sn: (b)(6) ) had an spo2 failure.As the unit was no longer under warranty, the customer informed technical support that they were going to send it out for repair, but not with nk/nka.No further details were provided.Service requested: troubleshooting.Service performed: customer had unit sent to third party for repair.Investigation result(s): root cause of the spo2 failure was unable to be identified due to lack of provided information from the customer and the device(s) in question could not be obtained for evaluation/investigation.Possible cause for the issue is failure of components due to age and use over time as the issue was reported one year after the end of warranty date.The device serial number history for the zm-540pa (sn: (b)(6) ) shows that there have been no further/previously reported issues nor servicing for spo2 failure.This suggests the issue was resolved through servicing the unit.Trending analysis found 3 similarly reported issues regarding zm-540pa spo2 failure/notworking.The three similarly reported events occurred over the span of two years, therefore an adverse trend is not suspected and there is no indication of design deficiency.Review of the device history record (dhr) shows that the unit has no history of ncmr, refurbishing, or other suspected defects (see attached).Further information is unattainable at this time and the reported device cannot be obtained for investigation/evaluation, therefore investigation by qa has been completed.Correction: f9.Approximate age of device: incorrectly calculated.
Event or Problem Description
The customer reported that the transmitter has an spo2 failure.No additional information regarding the event is available.No known impact or consequence to the patient.

• Brand Name: ZM-540PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7839601
• Report Number: 8030229-2018-00348
• Device Sequence Number: 1286901
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: 04931921106600
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019
• Report Date (Section F): 07/24/2019

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
• Operator of Device: Health Professional
• Device Model Number: ZM-540PA
• Device Catalogue Number: ZM-540PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2019
• Device Age: 72 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/24/2019