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

Catalog Number 2141PX3000

Device Problem Intermittent Loss of Power (4016)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2023

Event Type  malfunction  

Event Description

It was reported that while using the zoom feature on the device, with a patient on it, the power suddenly cut.As a result, the nurse tried manually move the bed and injured herself.The patient on the device was not impacted, but the nurse was injured.

Manufacturer Narrative

This report is a duplicate report of mfr report # 0001831750-2023-00976.The investigation findings regarding this device will be contained within the final mdr supplemental for that report.

Event Description

It was reported that while using the zoom feature on the device, with a patient on it, the power suddenly cut.As a result, the nurse tried manually move the bed and injured herself.The patient on the device was not impacted, but the nurse was injured.

• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17460168
• MDR Text Key: 320404672
• Report Number: 0001831750-2023-00973
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327472998
• UDI-Public: 07613327472998
• 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: 10/06/2023

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?: Yes
• Device Catalogue Number: 2141PX3000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 10/06/2023
• 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