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

Model Number 300900000000

Device Problems Complete Blockage (1094); Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/15/2022

Event Type  Injury  

Event Description

It was reported that the iv lines attached to the pump at the head end of the device were getting pinched when the user was putting them under the headboard slots when placing the headboard on the device.It was further reported that this caused an interruption in the patient receiving the medication which caused a drop in blood pressure.

Manufacturer Narrative

The alleged iv-line interruption resulting in a patient not receiving drugs was not due to any component level defect of the product as the rough edges identified appeared to be within specification.

Event Description

It was reported by that allegedly the iv line attached to the pump and the patient located at the back of the bed, was severed resulting in the patient not receiving inotropic drugs and their blood pressure dropping.An investigation was performed by the hospital which found that the headboard was removed and replaced resulting in trapped iv lines.The headboard was forced downward, severing the iv-line.The alleged iv-line interruption resulting in a patient not receiving drugs was not due to any component level defect of the product as the rough edges identified appeared to be within specification.

• Brand Name: PROCUITY BED
• 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: 15160290
• MDR Text Key: 297190670
• Report Number: 0001831750-2022-00891
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327512656
• UDI-Public: 07613327512656
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 300900000000
• Device Catalogue Number: 300900000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• 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): Other