MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO IN TOUCH ZU; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 2141000000

Device Problem Unintended Movement (3026)

Patient Problems Physical Entrapment (2327); Injury (2348)

Event Date 02/18/2014

Event Type  Injury  

Event Description

It was reported that a nurse was using an intouch bed with zoom drive to move a patient.The nurse was going in reverse when the bed allegedly zoomed and the nurse was caught in between.The nurse allegedly suffered injuries to her arm, shoulder and neck.Immediate medical attention was allegedly sought and care allegedly ongoing.

Event Description

It was reported that a nurse was using an intouch bed with zoom drive to move a patient.The nurse was going in reverse when the bed allegedly zoomed and the nurse was caught in between.The nurse allegedly suffered injuries to her arm, shoulder and neck.Immediate medical attention was allegedly sought and care allegedly ongoing.

Manufacturer Narrative

Follow-up submitted to report an evaluation was not performed as the serial number needed to identify the device involved in this event was not recorded.It was also reported by the customer that no records exist for this alleged issue.Bed not identified for evaluation.

• Brand Name: IN TOUCH ZU
• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3822764
• MDR Text Key: 4400750
• Report Number: 0001831750-2014-03004
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 2141000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2014
• 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