MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BED INTOUCH WITH ZOOM MOTOR; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 2141000000

Device Problems Break (1069); Collapse (1099)

Patient Problem Injury (2348)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

Stryker service rep visited the account and evaluated the bed.The customer decided not to have the bed fixed at this time.

Event Description

It was reported that the bed collapsed about six inches due to the actuator breaking from the mount.The patient alleged back injuries from the collapse, but the extent of the injuries and any possible medical intervention was reported.

• Brand Name: BED INTOUCH WITH ZOOM MOTOR
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6078494
• MDR Text Key: 59172261
• Report Number: 0001831750-2016-00335
• Device Sequence Number: 1
• Product Code: FNL
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2141000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2013
• 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