MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; STANDARD CART W/ ISOLATION TRANSFORMER; CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

Catalog Number 0240099011

Device Problems Sparking (2595); Electrical Shorting (2926)

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

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that there was sparking on plugging in the device.

Event Description

It was reported that there was sparking on plugging in the device.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: sparking probable root cause: too much heat transformer design cart design manufacturing nonconformity (tekna) use error the device manufacture date is not known.81.

• Brand Name: PKG; STANDARD CART W/ ISOLATION TRANSFORMER
• Type of Device: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10213549
• MDR Text Key: 197297234
• Report Number: 0002936485-2020-00250
• Device Sequence Number: 1
• Product Code: BZN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0240099011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1