FDA Adverse Event Other Summary report: N

2531468-2008-00001

MDR report key: 1033341 · Received April 7, 2008

Report

Report Number
2531468-2008-00001
Event Type
Other
Date Received
April 7, 2008
Product Code
IKX
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT OF THE MEDWATCH REPORT ON 3/11/08, THE HOVERTECH INT'L REP PHONED THE FACILITY ON 3/12/08 AND SPOKE WITH THE REPORTING PARTY. REP REAFFIRMED THAT THE PT WAS NOT INJURED DUE TO THE INCIDENT. WHEN ASKED IF THE HOVERMATT IN QUESTION COULD BE RETURNED TO HOVERTECH INT'L, SHE STATED IT WAS STILL IN SERVICE AND IT WAS NEVER NOTED WHICH MATT WAS INVOLVED WHEN THE INCIDENT OCCURRED. AT THAT TIME, FOUR DIFFERENT HM34HS MATTS WERE IN SERVICE AT THE FACILITY. CONSEQUENTLY, THERE IS NO SERIAL# TO RECORD OR PRODUCT TO EVALUATE. USING AN HM34HS FROM HOVERTECH'S INVENTORY, WE CANNOT DUPLICATE THE INCIDENT WHEN WE APPLY THE VARIABLES STATED IN THE EVENT DESCRIPTION. WE USED AN HM34HS WITH A FOUR-HUNDRED POUND WEIGHT, THE CART WHEELS LOCKED, POSITIONED NEXT TO A BED THAT WAS TWO INCHES LOWER THAN THE CART, ALSO WITH LOCKED WHEELS. PLEASE NOTE THAT THE HOSP BED WHEELS WERE LOCKED DURING OUR EVAL AS PART OF STANDARD TRANSFERRING PROTOCOL, ALTHOUGH THE FACILITY DID NOT SPECIFY THAT THE WHEELS OF THE BARIATRIC BED WERE LOCKED I N THEIR EVENT DESCRIPTION. USING ONLY TWO PEOPLE TO COMPLETE THE TRANSFER, IT WENT SMOOTHLY EACH TIME. THEREFORE, AS CORRECTIVE ACTION. THE HOVERTECH SALES REP HAS SCHEDULED A HOVERMATT RE-TRAINING SESSION FOR STAFF MEMBERS AT FACILITY FOR THE MONTH OF JUNE. OUR RECORDS SHOW THAT FACILITY ONLY HAS HM34HS HOVERMATTS AT ITS FACILITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 IKX HM34HS

Patients

Seq Age Sex Outcome Treatment
1