MAUDE Adverse Event Report: COVIDIEN MFG PLAINFIELD

Model Number 95251

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/27/17.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer states that the unit has a damaged main lead, and case.On (b)(6) 2017 service noted that the unit had a damaged power cord, copper wire was exposed.

Manufacturer Narrative

The scd express was evaluated and service noted that the unit had a damaged power cord, copper wire was exposed, the report also noted there was damage to the case.The cause of the reported condition for the damaged power cord was due to customer misuse and is supported by the other observed damage to the case of the device indicating a traumatic impact to the device occurred.The power cord in addition to the case, compressor and valve block were replaced (compressor and valve block as part of routine service).The device was retested and returned to the customer.The unit passed testing after repairs were completed.A review of the device history record shows this device was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the unit has a damaged main lead, and case.On (b)(6) 2017 service noted that the unit had a damaged power cord, copper wire was exposed.

• Manufacturer (Section D): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6361501
• MDR Text Key: 68752390
• Report Number: 3008361498-2017-05019
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95251
• Device Catalogue Number: 95251
• Device Lot Number: V0524262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1