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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND NELLCOR; OXIMETER

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NELLCOR PURITAN BENNETT IRELAND NELLCOR; OXIMETER Back to Search Results
Model Number PM1000N
Device Problems Device Alarm System (1012); Use of Device Problem (1670); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2023
Event Type  malfunction  
Event Description
According to the reporter, prior to use, the unit's lcd touch screen was not working at all.The internal cable was able to be reseated and fixed the issue, however the unit was silencing itself.There were no audible or visual alarms.It was a failure out of box.There was no patient involvement.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit found no damages.The device was powered on, passing post with audible tones present.After post, it was verified that the touchscreen was not responsive.An src-max(cl-13446) was connected to the device, the device took readings properly.Alarm limits were then simulated, the device alarmed both visibly and audibly.The device was left to alarm for two hours, the device delivered visual and audible alarms through the entirety of this time.The alarm silence was not self-activated.The touchscreen flex cable was reseated, the touchscreen was still not responsive.After replacing the liquid crystal display (lcd) assembly, the touchscreen functioned properly.The silence alarm button was pressed and was verified to function properly as well.It was reported that the touch screen was defective.The reported issue was confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
NELLCOR
Type of Device
OXIMETER
Manufacturer (Section D)
NELLCOR PURITAN BENNETT IRELAND
micheal collins rd mervue
galway
EI 
Manufacturer (Section G)
NELLCOR PURITAN BENNETT IRELAND
micheal collins rd mervue
galway
EI  
Manufacturer Contact
justin ellis
8200 coral sea st ne
mounds view, MN 55112
7635265677
MDR Report Key17078476
MDR Text Key316867658
Report Number8020893-2023-00343
Device Sequence Number1
Product Code DQA
UDI-Device Identifier10884521182530
UDI-Public10884521182530
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/16/2023
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 NumberPM1000N
Device Catalogue NumberPM1000N
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/22/2023
Initial Date FDA Received06/07/2023
Supplement Dates Manufacturer Received07/24/2023
Supplement Dates FDA Received08/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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