MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND; OXIMETER, TISSUE SATURATION

Model Number	5100C-PA
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit had bad signal and defective connection to preamp.Customer indicated there was no patient harm.
Additional Manufacturer Narrative
Additional information: evaluation summary: one device was returned for evaluation.The reported event was not confirmed.The investigation isolated the failure to the housing damage.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit had bad signal and defective connection to preamp.The device was getting erratic readings.Customer indicated there was no patient harm.

• Brand Name: NA
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• MDR Report Key: 7801654
• Report Number: 8020893-2018-00386
• Device Sequence Number: 2507438
• Product Code: MUD
• UDI-Device Identifier: 10884521145573
• UDI-Public: 10884521145573
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

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: 5100C-PA
• Device Catalogue Number: 5100C-PA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1