SANDHILL SCIENTIFIC
Received May 27, 2020 · Event occurred Mar 13, 2020
Report 10091552 · MDR key 10091552
Device
Generic name
System, Gastrointestinal Motility (electrical)
Manufacturer
Diversatek Healthcare, Inc.Model number
Z07-2000-B-BCatalog number
Z07-2000-B-B
Product problems
- Computer Operating System Problem
Patient
12045 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PATIENT HAD A 24HR ESOPHAGEAL IMPEDANCE PH CATHETER PLACED. HE WAS DUE TO RETURN FOR CATHETER REMOVAL AND STUDY DOWNLOAD ON THE FOLLOWING DAY AT 1400. HE CALLED ON THE MORNING OF THE PROCEDURE TO REPORT THAT THE MONITOR HAD STOPPED WORKING. PATIENT WAS ADVISED TO RETURN TO UNIT AT THAT TIME BUT DID NOT RETURN UNTIL THAT AFTERNOON. MOTILITY RN WAS NOT AVAILABLE TO REMOVE THE CATHETER AT THAT TIME. CATHETER WAS REMOVED BY ANOTHER ENDOSCOPY RN. MOTILITY RN ATTEMPTED TO DOWNLOAD STUDY UNSUCCESSFUL. SD CARD CONTAINING STUDY WAS MAILED TO DIVERSATEK HEALTH TO BE ANALYZED. THEY WERE NOT ABLE TO RETRIEVE STUDY. RECORD IS BEING SENT OUT FOR REPAIR.