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

Model Number ZM-540PA

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 119039048
• Report Number: 8030229-2018-00348
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: 04931921106600
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 07/24/2019
• Distributor Facility Aware Date: 07/24/2019
• Device Age: 72 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2019
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1