MAUDE Adverse Event Report: STRYKER CORPORATION INTOUCH; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number QDF27-2188 ENG

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2018

Event Type  malfunction  

Event Description

The stryker in-touch bed mattress failed resulting in the patient resting on metal frame.This required movement to another bed with risk for et tube dislodgement.Mattress deflated.

• Brand Name: INTOUCH
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER CORPORATION; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 8189339
• MDR Text Key: 131199184
• Report Number: 8189339
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: QDF27-2188 ENG
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30660 DA