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

Model Number ZM-531PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Invalid Sensing (2293)

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

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the transmitter gave inaccurate spo2 readings.They tried a new spo2 sensor, however the issue persisted.There was no physical damage or fluid intrusion reported.The device was in use on a patient, but no patient harm was reported.They were provided with an exchanged device to resolve the issue.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 gave inaccurate spo2 readings.

Manufacturer Narrative

The biomedical engineer reported that the transmitter gave inaccurate spo2 readings.They tried a new spo2 sensor, however the issue persisted.There was no physical damage or fluid intrusion reported.The device was in use on a patient, but no patient harm was reported.They were provided with an exchanged device to resolve the issue.The investigation has determined the complaint involves a hardware malfunction with a bsm that has been resolved by replacing the product.

• Brand Name: ZM-531PA
• 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; 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; JA 359-8580
• MDR Report Key: 6704619
• MDR Text Key: 79781090
• Report Number: 8030229-2017-00229
• 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: 07/11/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 07/11/2017
• Distributor Facility Aware Date: 06/12/2017
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2017
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 07/11/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• 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