MAUDE Adverse Event Report: COVIDIEN COMPRESSION SYSTEM SCD 700; SLEEVE, LIMB, COMPRESSIBLE

Model Number	MC-SCD700
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	01/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the patient was in the medical ward and the device kept on beeping multiple times.It was not working for most of the night.The patient¿s treatment was changed to clexane.She was transferred to (b)(6).Early the next morning, the patient had sharp chest pain indicating a possible pulmonary embolism.The patient was blue lighted to (b)(6) in the evening.She was found to have a left pulmonary embolism extending from the main pulmonary artery to segmental and subsegmental artery.

• Brand Name: COMPRESSION SYSTEM SCD 700
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9695453
• Report Number: 1282497-2020-08922
• Device Sequence Number: 1691119
• Product Code: JOW
• UDI-Device Identifier: 10884521155688
• UDI-Public: 10884521155688
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: MC-SCD700
• Device Catalogue Number: MC-SCD700
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1