VAC-PAC
Received Jan 17, 2018
Report 3018859-2018-00049 · MDR key 7201989
Device
Product problems
- Use of Device Problem
- Torn Material
- Use of Device Problem
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NATUS MEDICAL INVESTIGATION FOUND EVIDENCE THAT A CUT NEAR THE CORNER WAS DETECTED ON THE VAC PAC. CUSTOMERS ARE INSTRUCTED BY THE INSTRUCTION MANUAL TO INSPECT THE VAC-PAC PRIOR TO EACH USE. THE CUSTOMER HAD THE VAC-PAC DESTROYED AT THE FACILITY, TO PREVENT FUTURE USE. THE CUSTOMER HAS SINCE BEEN PROVIDED A REPLACEMENT. NO FURTHER INVESTIGATION IS NECESSARY, AND THIS REPORT IS CONSIDERED FINAL.
Description of Event or Problem
NATUS MEDICAL RECEIVED A COMPLAINT THAT ON (B)(6) 2017 A VAC-PAC HAD CUT NEAR THE CORNER. NO PATIENT INVOLVED REPORTED.
Additional Manufacturer Narrative
CORRECTION: THERE WAS NO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.
Remedial action
- Replace