DIAGNOST 76 PLUS NI MFR5102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-09-15 for DIAGNOST 76 PLUS NI MFR5102 manufactured by Philips Systeme Medezin.

Event Text Entries

[102452] Reportedly, when the technologist moved the tabletop in the longitudinal direction, the pt's fingers allegedly got caught under the tabletop pinching them against the table. No serious injury reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1217116-1997-00030
• MDR Report Key: 121152
• Report Source: 05,06
• Date Received: 1997-09-15
• Date of Report: 1997-08-16
• Date of Event: 1997-08-03
• Date Facility Aware: 1997-08-03
• Report Date: 1997-08-16
• Date Reported to Mfgr: 1997-08-16
• Date Mfgr Received: 1997-08-16
• Date Added to Maude: 1997-09-23
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Remedial Action: RP
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DIAGNOST 76 PLUS
• Generic Name: GENERAL PURPOSE R/F SYSTEM
• Product Code: IXQ
• Date Received: 1997-09-15
• Model Number: NI
• Catalog Number: MFR5102
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 118731
• Manufacturer: PHILIPS SYSTEME MEDEZIN
• Manufacturer Address: * HAMBURG GM
• Baseline Brand Name: DIAGNOST 76 PLUS
• Baseline Generic Name: GENERAL PURPOSE R/F SYSTEM
• Baseline Model No: NI
• Baseline Catalog No: MFR5102
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-09-15