MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number ZM-541PA

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reports that the transmitter is giving an inaccurate spo2 reading and changes constantly.There is no sign of fluid intrusion.A replacement transmitter was sent to the customer.Device was returned, evaluated and duplicated.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 biomedical engineer reports that the transmitter is giving an inaccurate spo2 reading and changes constantly.There is no sign of fluid intrusion.A replacement transmitter was sent to the customer.

Manufacturer Narrative

Manufacturer narrative: the biomedical engineer reports that the transmitter is giving an inaccurate spo2 reading and changes constantly.There is no sign of fluid intrusion.A replacement transmitter was sent to the customer.The unit was evaluated and the reported problem was duplicated.Upon inspection it was found that this unit will be sent to nkc for an evaluation due to an electronic malfunction, unit was cleaned.The customer was sent an exchange unit.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-541PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; 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 ; 2687488
• MDR Report Key: 5509628
• MDR Text Key: 40653020
• Report Number: 8030229-2016-00108
• Device Sequence Number: 1
• Product Code: DRT
• 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,Followup
• Report Date: 03/17/2016,02/16/2016

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-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 03/17/2016
• Distributor Facility Aware Date: 02/16/2016
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2016
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided; 03/17/2016
• Supplement Dates FDA Received: 05/22/2017; 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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