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

Device Problem Inflation Problem (1310)

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

Event Date 01/22/2019

Event Type  malfunction  

Event Description

Stryker intouch beds deflate without warning.

Event Description

Stryker intouch beds deflate without warning.

• 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: 8307329
• MDR Text Key: 135135654
• Report Number: 8307329
• 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
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1