MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY LEX WITH ISOTOUR STD; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 3009PX-LEX-400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported that the bed exit did not alarm and a patient fall occurred.It was further reported that the patient sustained a subdural hematoma and was transferred to the icu for further monitoring and no surgical intervention was required.Further treatment information could not be obtained and no defect was found with the device.

Manufacturer Narrative

Added manufacturing date.

Event Description

It was reported that the bed exit did not alarm and a patient fall occurred.It was further reported that the patient sustained a subdural hematoma and was transferred to the icu for further monitoring and no surgical intervention was required.Further treatment information could not be obtained and no defect was found with the device.

• Brand Name: PROCUITY LEX WITH ISOTOUR STD
• 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: melissa millard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 15793656
• MDR Text Key: 303621212
• Report Number: 0001831750-2022-01219
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327541229
• UDI-Public: 07613327541229
• 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,Followup
• Report Date: 04/14/2023

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 Model Number: 3009PX-LEX-400
• Device Catalogue Number: 3009PX-LEX-400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2020
• 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): Other