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

Catalog Number UNK_MED

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Head Injury (1879)

Event Date 05/01/2021

Event Type  malfunction  

Event Description

It was reported that a patient fell from the bed and the alarm did not sound at the nurse station.It was further reported that the patient sustained a head injury and passed away while being taken for a ct scan.The user facility did not provide a model or serial number and attempts are being made to gather more details regarding the patient death.

Manufacturer Narrative

It was initially reported that a patient passed away as a result of a fall.Upon follow up from the user facility it was found that the death was unrelated to the fall and the only adverse consequence that the patient suffered was a nondisplaced fracture.The user facility stated this fracture would not have required any treatment.Section b5 has been updated to reflect this.The user facility performed their own device evaluation and require no further action from stryker.H3 other text : user facility performed the device evaluation and required no further action.

Event Description

It was reported that a patient fell from the bed and the alarm did not sound at the nurse station.It was further reported that while being taken for a ct scan the patient passed away.Upon follow up with the user facility it was confirmed that the death was unrelated to the fall and that the only adverse consequence related to the fall was a nondisplaced fracture, which would not have required medical treatment.The user facility performed their own device evaluation and repairs and require no further action from stryker.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11940893
• MDR Text Key: 254328643
• Report Number: 0001831750-2021-00938
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death