MalfunctionCBF
SECHRIST HYPERBARIC CHAMBER
Received Aug 11, 2023
Report MW5123303 · MDR key 17516354
Device
Generic name
Chamber, Hyperbaric
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED THAT A SECHRIST HYPERBARIC CHAMBER, SERIAL NUMBER (B)(6), HAD A MALFUNCTIONING HEAD SECTION. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).