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

Catalog Number 2141000000

Device Problems Device Alarm System (1012); Incorrect Or Inadequate Test Results (2456)

Patient Problems Fall (1848); Injury (2348)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

Several attempts have been made to reach the account for further information, however no response has been received as of the filing date.

Event Description

It was reported the scale was inaccurate due to the bed not being zeroed properly.It was further reported a patient fell from the bed, and the bed exit allegedly did not alarm.It was alleged the patient sustained an injury, but no additional details were 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6961907
• MDR Text Key: 89732203
• Report Number: 0001831750-2017-00459
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• 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: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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