MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS KENDALL SCD; SLEEVE, LIMB, COMPRESSIBLE

Model Number	295250
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submitted september 28, 2018 the unit has been received for evaluation.When additional information is completed a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports that there was a booting failure with an audible alarm.A component on the mainboard was burnt.
Additional Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the customer reports that there was a booting failure with an audible alarm.A component on the mainboard was burnt.¿ the device history record (dhr) for serial number (b)(4) indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.Product cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.The unit was returned to the service center and an evaluation was performed.Thermal damage to the mainboard was visually confirmed.Not all internal components were observed as burnt.The thermal damage to the mainboard appears to be related to over-current or over voltage.The potential root cause was identified as a faulty component, such as a voltage regulator or resistor.A request for further information was made.However, no additional information was provided.Therefore, a root cause could not be determined.The customer also cancelled the service request.The reported customer complaint was confirmed.A specific root cause could not be determined.A probable root cause was determined to be a faulty component.No corrective or preventive action is planned at this time.This information will be utilized for trending purposes to determine the need for corrective actions.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KENDALL SCD
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; covidien 20111 4; CN 201114
• MDR Report Key: 7920487
• Report Number: 3006451981-2018-00609
• Device Sequence Number: 1346540
• Product Code: JOW
• UDI-Device Identifier: 10884521129573
• UDI-Public: 10884521129573
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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: 295250
• Device Catalogue Number: 295250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1