MAUDE Adverse Event Report: COVIDIEN

Model Number UNK EF

Device Problems Loss of Power (1475); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.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.

Event Description

The customer reports that during use on a patient, the unit shut off.The customer stated that the patient was underfed by an unspecified amount as a result.No patient injury or medical intervention required.

Manufacturer Narrative

Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

To date, the unit has not been received for evaluation.Without the unit, a detailed investigation could not be performed and the reported condition could not be confirmed.This complaint file shall be closed as unconfirmed at this time.If the unit is returned, the complaint shall be re-opened.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6364108
• MDR Text Key: 68992983
• Report Number: 1282497-2017-05032
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2017

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: No Information
• Device Model Number: UNK EF
• Device Catalogue Number: UNK EF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/28/2017
• Supplement Dates Manufacturer Received: 01/30/2017; 01/30/2017
• Supplement Dates FDA Received: 09/06/2017; 11/02/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR