PARATREAD 7 SENSOR MPS7004

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 1998-01-18 for PARATREAD 7 SENSOR MPS7004 manufactured by Diametrics Medical, Ltd..

Event Text Entries

[16481626] Customer reported a anomalous reading during monitoring. No report of injury to pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9612233-1998-90001
• MDR Report Key: 145186
• Report Source: 05,06
• Date Received: 1998-01-18
• Date of Report: 1998-01-15
• Date of Event: 1997-12-31
• Date Mfgr Received: 1998-01-07
• Date Added to Maude: 1998-01-26
• 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: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PARATREAD 7 SENSOR
• Generic Name: BLOOD GAS MONITORING SYSTEM
• Product Code: CCC
• Date Received: 1998-01-18
• Model Number: MPS7004
• Catalog Number: MPS7004
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 141548
• Manufacturer: DIAMETRICS MEDICAL, LTD.
• Manufacturer Address: GEORGE ST. HIGH WYCOMBE, BUCKS. UK HP11 2XJ
• Baseline Brand Name: PARATREND 7 SENSOR
• Baseline Generic Name: BLOOD GAS MONITORING SYSTEM
• Baseline Model No: MPS7004
• Baseline Catalog No: MPS7004
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-01-18