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

Model Number ZM-530PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper Device Output (2953)

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

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the spo2 is not giving an accurate reading.The customer has tried a new cable and probe but the problem persists.There is no physical damage or fluid intrusion that he is aware of.Customer is sending in the unit to be exchanged.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 customer reported that the spo2 is not giving an accurate reading.

Manufacturer Narrative

Corrected data: device available for evaluation, device evaluated by manufacturer, additional manufacturer narrative.Additional information: type of report?: follow up, type of report: follow up, if follow-up, what type? additional information/correction.Event problem and evaluation codes.The customer reported that the spo2 is not giving an accurate reading.The customer has tried a new cable and probe but the problem persists.There is no physical damage or fluid intrusion that he is aware of.Customer has sent in the unit to be exchanged.The malfunctioning unit was cleaned and evaluated.The reported problem of "spo2 is not giving an accurate reading" was not duplicated.During investigation it was also determined that the front, rear and center cases need to be replaced due to badly discoloring.All malfunctioning parts were replaced.The unit completed 24 hours of extended testing and operates to manufacturer's specifications.

• 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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, 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
• MDR Report Key: 7010919
• MDR Text Key: 91374140
• Report Number: 8030229-2017-00394
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• 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: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 11/08/2017
• Distributor Facility Aware Date: 10/09/2017
• Device Age: 91 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2017
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2010
• 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