MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO INTOUCH WIFI ZOOM BED PREV PCK; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 2141PX3000

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced iv pole falls from upright position in an unintended direction.There was 1 event with patient involvement; no adverse consequences were reported.

Manufacturer Narrative

The 1 pending device was not evaluated, as the issue was identified and resolved through communication/interviews with the user facility; the issue was confirmed.Section h codes have been updated.An additional event was identified and therefore added to this summary report.

Event Description

This report summarizes 2 malfunction events, where it was reported the device experienced iv pole falls from upright position in an unintended direction.There was 2 event with patient involvement; no adverse consequences were reported.

• Brand Name: INTOUCH WIFI ZOOM BED PREV PCK
• 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 simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18574362
• MDR Text Key: 333697800
• Report Number: 0001831750-2024-00270
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 2141PX3000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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