MAUDE Adverse Event Report: COVIDIEN ALTITUDE; APPARATUS, AUTOTRANSFUSION

Model Number 8888571370

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/22/17.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states air in drainage.

Manufacturer Narrative

An investigation into the reported condition was performed.The complaint report indicates that no sample is available in connection with this complaint report.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).Unfortunately without a sample we are unable to confirm the reported condition if a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot 17d098fhx.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ALTITUDE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer (Section G): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7143721
• MDR Text Key: 95729695
• Report Number: 9611018-2017-05015
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 20884521060972
• UDI-Public: 20884521060972
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2022
• Device Model Number: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 17D098FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1