MAUDE Adverse Event Report: ZIMMER SURGICAL HEMOVAC COMPACT EVACUATOR KIT; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Catalog Number 00-2500-000-10

Device Problems Break (1069); Occlusion Within Device (1423)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2015

Event Type  malfunction  

• Brand Name: HEMOVAC COMPACT EVACUATOR KIT
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 4870733
• Report Number: 4870733
• Device Sequence Number: 1
• Product Code: GCY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 00-2500-000-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 122