MAUDE Adverse Event Report: CAREMED SUPPLY, INC. MEDLINE VASO-FORCE; SLEEVE, LIMB, COMPRESSIBLE

Model Number MDS600

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 09/09/2015

Event Type  malfunction  

Event Description

The bed hooks on the device are easily broken.There has been an updated part released, but this new part breaks just as the first one did.Manufacturer response for sequential compression pump, vaso-force (per site reporter): to sell us new bed hooks.

• Brand Name: MEDLINE VASO-FORCE
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CAREMED SUPPLY, INC.; 4025 tampa rd fl 1117; oldsmar FL 34677
• MDR Report Key: 5103769
• MDR Text Key: 26738559
• Report Number: 5103769
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: MDS600
• Device Lot Number: 11102103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1