MAUDE Adverse Event Report: COVIDIEN KENDALL SCD 700 SERIES CONTROLLER, US M; SLEEVE, LIMB, COMPRESSIBLE

Model Number	29525B
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained 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.
Event or Problem Description
The customer reported the device was attached to the end of the bed and when it was switched on, there was a bang and a flash where the cable connects to the unit.This resulted in the main circuit breaker within the local distribution board tripping.The customer also reported there was an unknown pinkish fluid dripping from the main cable connected to the machine.The unit had been in use in theater prior to this incident and had been returned to the maternity ward.
Additional Manufacturer Narrative
All device history records were reviewed to ensure that products were released meeting all quality release specifications at the time of manufacture.The device was returned for evaluation.The reported issue was not duplicated.The inspection included the casing and inner contents of the unit.In addition, compression, valve, kink, inductor and leak tests were performed.Upon inspection and triage there was no trace or indication of sparking or fire.There was no blackened housing or burnt cables.Replacement was made to the lcd, controller, power cord and power supplier to upgrade or replace damaged parts.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.

• Brand Name: KENDALL SCD 700 SERIES CONTROLLER, US M
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9758796
• Report Number: 1282497-2020-08942
• Device Sequence Number: 19479869
• Product Code: JOW
• UDI-Device Identifier: 10884521129627
• UDI-Public: 10884521129627
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: No Information
• Device Model Number: 29525B
• Device Catalogue Number: 29525B
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1