MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO DUO GARD BED CUSHION; BED, FLOTATION THERAPY, POWERED

Catalog Number DG212

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Fall (1848)

Event Date 12/23/2013

Event Type  Death  

Event Description

It was reported that while on a dg212 overlay a patient allegedly fell and later expired.It was reported that the overlay was incorrectly used by the nursing staff on an unidentified stretcher which raised the height allowing the patient to roll off the stretcher and onto the floor.The patient expired several days later; however, it was reportedly due to pre-existing conditions and no malfunction of the overlay was alleged.

Manufacturer Narrative

The serial number of the overlay was not recorded by the customer in order to identify and perform an evaluation.No malfunction of the overlay was alleged.Customer could not identify overlay in order to perform an evaluation.

• Brand Name: DUO GARD BED CUSHION
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3574492
• MDR Text Key: 4060070
• Report Number: 0001831750-2014-00381
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: DG212
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death