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U.S. Department of Health and Human Services

Class 2 Device Recall TotalCare Bed

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  Class 2 Device Recall TotalCare Bed see related information
Date Initiated by Firm May 30, 2013
Date Posting Updated July 23, 2013
Recall Status1 Terminated 3 on April 17, 2014
Recall Number Z-1794-2013
Recall Event ID 65259
Product Classification Bed, flotation therapy, powered - Product Code IOQ
Product TotalCare Bed used with AccuMax Quantum VPC mattress
AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress

The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Code Information Bed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384.

The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact
812-934-7777
Manufacturer Reason
for Recall
When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to get back into the bed may miss the seat and sit on the foot section instead. The patient can slide down to the floor, or fall, with possible injury.
FDA Determined
Cause 2
Device Design
Action The firm, Hill-Rom, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 29, 2013 was sent to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Until the correction is implemented, after placing the bed into chair position, regularly check the foot section of the mattress. If necessary, push it back against the bed frame until the magnets hold it in place before allowing the patient to get back into or out of bed. In addition, forward a copy of this letter to any other facility personnel you deem appropriate. If you have any questions concerning this notification, please contact your distributor, your Hill-Rom representative, or Hill-Rom Technical Support at 800-445-3720 (Mon-Thurs, 8 am-6:30 pm; Friday, 8 am-6 pm).
Quantity in Commerce 4,121 Units
Distribution Worldwide distribution: USA (nationwide) and countries of: Canada, Colombia, Nigeria, Kuwait and Saudi Arabia.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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